Alzheimer's Disease
Conditions
Keywords
Alzheimer's Disease, naturalistic study
Brief summary
To characterize the comorbidities and medications of patients treated with donepezil in a routine clinical practice and to verify the therapeutic response of these patients.
Detailed description
This trial was terminated prematurely on December 31, 2007 due to difficulties in enrolling patients in the study. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
Interventions
OTHERdonepezil
Routine clinical practice of prescribing donepezil as per the Canadian label. No drug was supplied as part of this study
Sponsors
Pfizer
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* DSM-IV criteria for the clinical diagnosis of mild to moderate Alzheimer's Disease with or without other etiologies of dementia * Mini Mental Status Examination score of 10-26
Exclusion criteria
* Contraindication as stated in the Canadian label for donepezil * Subjects treated with medication for dementia within 30 days prior to baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Attention symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline and Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Repetitiveness symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Remembering symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Temporal Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Asphasia symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Spatial Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to categories: Improved/Stabilized=4,5,6; Worsened=2,3 |
| All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Judgment symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Insight symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Leisure symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Domestic Activities symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Hygiene symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Dressing symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Telephoning symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Agitation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Mood symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Anxiety symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Delusions symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Apathy symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Caregiver symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
| All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Baseline and Week 12 | Severity symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12 | baseline, Week 12 | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline. |
| Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF | baseline, Week 12 LOCF | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression (none, moderate or extreme anxiety/depression). Analysis of difference between the proportion of subjects with any problem and no problem at baseline versus at Week 12 LOCF |
| Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12 | baseline, Week 12 LOCF | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline |
| Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score | baseline, 12 Weeks | MMSE cognitive function: Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole using scale: 1 (poor) - 4 (excellent), possible total 13 - 52. Separate ratings from both patient and caregiver. |
| Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score | baseline, Week 12 LOCF | MMSE cognitive function. Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver |
| Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores | baseline, 12 Weeks | Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline. |
| LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores | baseline, 12 Week LOCF | Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline. |
| Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs) | baseline, 12 Weeks | QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Patient and the caregiver totals combined and correlated to number of treatment emergent adverse events. |
| Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs) | baseline, 12 Weeks LOCF | QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Ratings from patient and the caregiver combined and correlated with number of treatment emergent adverse events. |
| Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D) | baseline, 12 Weeks | EQoL-5D: measures index of health and defines it in 5 Domains:mobility,self-care,usual activities, pain/discomfort, anxiety/depression. Each domain evaluated on 3-point scale yielding 243 potential combinations; converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change: Week 12 mean score minus baseline mean score |
| LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D) | baseline, 12 Weeks LOCF | EQoL-5D: measures index of health & defines it in 5 Domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each evaluated on 3-point scale yielding 243 potential combinations converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change:Week 12 mean score minus baseline mean score |
| Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire | baseline, 12 Weeks | EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline. |
| LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire | baseline, 12 Weeks LOCF | EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline. |
| Change From Baseline in Subject's Mobility at Week 12 | baseline, 12 Weeks | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12. |
| Change From Baseline in Subject's Mobility at Week 12 LOCF | Week 12 LOCF | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF |
| Change From Baseline in Subject's Self-Care at Week 12 | baseline, Week 12 | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12 |
| Change From Baseline in Subject's Self-Care at Week 12 LOCF | baseline, 12 Weeks LOCF | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12 LOCF. |
| Change From Baseline in Subject's Usual Activities at Week 12 | baseline, Week 12 | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities(no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12. |
| Change From Baseline in Subject's Usual Activities at Week 12 LOCF | baseline, 12 Weeks LOCF | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities (no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12 LOCF |
| Change From Baseline in Subject's Pain/Discomfort at Week 12 | baseline, Week 12 | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12. |
| Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF | Week 12 LOCF | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF |
| Change From Baseline in Subject's Anxiety/Depression at Week 12 | baseline, Week 12 | EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression(none, moderate or extreme anxiety/depression). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12. |
Participant flow
Recruitment details
This was a non interventional study conducted at 62 sites in Canada.
Pre-assignment details
Subjects had a diagnosis of mild to moderate Alzheimer's Disease with or without other etiologies of dementia.
Participants by arm
| Arm | Count |
|---|---|
| Donepezil As per physician prescription | 370 |
| Total | 370 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 30 |
| Overall Study | Death | 4 |
| Overall Study | Does not meet entrance criteria | 1 |
| Overall Study | Family discontinued meds | 1 |
| Overall Study | Family does not want continuation | 1 |
| Overall Study | Family wanted meds stopped | 1 |
| Overall Study | hospitalized due to deterioration | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Patient forgot to take meds | 1 |
| Overall Study | patient never took the medication | 1 |
| Overall Study | patient took for 2 days then stopped | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Syndrome De Glissement | 1 |
| Overall Study | week 12 not done | 1 |
| Overall Study | Withdrawal by Subject | 17 |
Baseline characteristics
| Characteristic | Donepezil |
|---|---|
| Age, Continuous | 80.1 years STANDARD_DEVIATION 7.5 |
| Sex: Female, Male Female | 172 Participants |
| Sex: Female, Male Male | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 54 / — |
| serious Total, serious adverse events | 12 / — |
Outcome results
Primary
All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Agitation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 157 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 23 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 142 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Anxiety symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 195 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 37 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 90 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Apathy symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 187 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 27 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 108 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Asphasia symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 104 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 190 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 28 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Attention symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline and Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT) : All subjects who did not have a response for post baseline assessment were not included in analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 202 Participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 31 Participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 89 Participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Caregiver symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 213 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 30 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 79 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 196 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 36 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 90 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Delusions symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 139 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 16 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 167 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Domestic Activities symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 198 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 23 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 101 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Dressing symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 152 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 23 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 147 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hygiene symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 168 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 23 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 131 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Insight symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 209 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 34 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 79 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Judgment symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 30 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 206 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 86 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Leisure symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 205 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 28 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 89 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Mood symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 187 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 38 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 97 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Remembering symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 231 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 44 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 47 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Repetitiveness symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 195 Participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 32 Participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 95 Participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Severity symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 233 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 40 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 49 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Spatial Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to categories: Improved/Stabilized=4,5,6; Worsened=2,3
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 96 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 201 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 25 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Telephoning symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 190 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 16 participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 116 participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Primary
All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Temporal Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time frame: Baseline and Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Improved or Stabilized | 209 Participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Worsened | 39 Participants |
| Donepezil | All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment | Missing/Not Applicable | 74 Participants |
Comparison: null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5p-value: <0.0001Binomial test of proportions
Secondary
Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores
Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.
Time frame: baseline, 12 Weeks
Population: Intent to Treat (ITT). (n= 207; number of subjects who responded)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores | 1.4 score on scale | Standard Deviation 3.36 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline.
Time frame: baseline, Week 12
Population: Intent to Treat (ITT): (n=288; number of subjects responding)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12 | 1.1 score on scale | Standard Deviation 2.75 |
Comparison: Change from baseline in total score at Week 12p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Subject's Anxiety/Depression at Week 12
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression(none, moderate or extreme anxiety/depression). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12.
Time frame: baseline, Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Anxiety/Depression at Week 12 | Any Problem | 158 Participants |
| Donepezil | Change From Baseline in Subject's Anxiety/Depression at Week 12 | No Problem | 132 Participants |
p-value: 0.0131McNemar
Secondary
Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression (none, moderate or extreme anxiety/depression). Analysis of difference between the proportion of subjects with any problem and no problem at baseline versus at Week 12 LOCF
Time frame: baseline, Week 12 LOCF
Population: Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF | Any Problem | 179 Participants |
| Donepezil | Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF | No Problem | 142 Participants |
p-value: 0.0078McNemar
Secondary
Change From Baseline in Subject's Mobility at Week 12
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12.
Time frame: baseline, 12 Weeks
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Mobility at Week 12 | Any Problem | 129 participants |
| Donepezil | Change From Baseline in Subject's Mobility at Week 12 | No Problem | 161 participants |
p-value: 0.7963McNemar
Secondary
Change From Baseline in Subject's Mobility at Week 12 LOCF
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF
Time frame: Week 12 LOCF
Population: Intent to Treat (ITT) LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Mobility at Week 12 LOCF | No Problem | 174 Participants |
| Donepezil | Change From Baseline in Subject's Mobility at Week 12 LOCF | Any Problem | 147 Participants |
p-value: 1McNemar
Secondary
Change From Baseline in Subject's Pain/Discomfort at Week 12
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12.
Time frame: baseline, Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Pain/Discomfort at Week 12 | Any Problem | 147 Participants |
| Donepezil | Change From Baseline in Subject's Pain/Discomfort at Week 12 | No Problem | 143 Participants |
p-value: 1McNemar
Secondary
Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the proportion of subjects with any problem at baseline versus Week 12 LOCF
Time frame: Week 12 LOCF
Population: Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF | Any Problem | 162 Participants |
| Donepezil | Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF | No Problem | 159 Participants |
p-value: 1McNemar
Secondary
Change From Baseline in Subject's Self-Care at Week 12
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12
Time frame: baseline, Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Self-Care at Week 12 | No Problem | 168 participants |
| Donepezil | Change From Baseline in Subject's Self-Care at Week 12 | Any Problem | 122 participants |
p-value: 0.0719McNemar
Secondary
Change From Baseline in Subject's Self-Care at Week 12 LOCF
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12 LOCF.
Time frame: baseline, 12 Weeks LOCF
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Self-Care at Week 12 LOCF | Any Problem | 140 Participants |
| Donepezil | Change From Baseline in Subject's Self-Care at Week 12 LOCF | No Problem | 181 Participants |
p-value: 0.1779McNemar
Secondary
Change From Baseline in Subject's Usual Activities at Week 12
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities(no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12.
Time frame: baseline, Week 12
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Usual Activities at Week 12 | Any Problem | 181 Participants |
| Donepezil | Change From Baseline in Subject's Usual Activities at Week 12 | No Problem | 109 Participants |
p-value: 1McNemar
Secondary
Change From Baseline in Subject's Usual Activities at Week 12 LOCF
EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities (no problem, some problem, unable to perform). Analysis of difference between the number of subjects with any problem and no problem at baseline versus at Week 12 LOCF
Time frame: baseline, 12 Weeks LOCF
Population: Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Donepezil | Change From Baseline in Subject's Usual Activities at Week 12 LOCF | Any Problem | 203 Participants |
| Donepezil | Change From Baseline in Subject's Usual Activities at Week 12 LOCF | No Problem | 118 Participants |
p-value: 0.8575McNemar
Secondary
Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire
EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.
Time frame: baseline, 12 Weeks
Population: Intent to Treat (ITT): (n=286; number of subjects responding).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire | 3.7 score on scale | Standard Deviation 10.55 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
EQoL-5D: measures index of health and defines it in 5 Domains:mobility,self-care,usual activities, pain/discomfort, anxiety/depression. Each domain evaluated on 3-point scale yielding 243 potential combinations; converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change: Week 12 mean score minus baseline mean score
Time frame: baseline, 12 Weeks
Population: Intent to Treat (ITT) (n=290; number of subjects responding)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D) | 0.015 score on scale | Standard Deviation 0.1071 |
p-value: 0.0152t-test, 2 sided
Secondary
Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs)
QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Patient and the caregiver totals combined and correlated to number of treatment emergent adverse events.
Time frame: baseline, 12 Weeks
Population: Intent to Treat (ITT). (n=207 number of subjects responding)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Donepezil | Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs) | -0.13 Pearson Product Correlation Coefficient |
p-value: 0.0713correlation coefficient
Secondary
Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs)
QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Ratings from patient and the caregiver combined and correlated with number of treatment emergent adverse events.
Time frame: baseline, 12 Weeks LOCF
Population: Intent to Treat (ITT) LOCF: (n=231; number of patients responding)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Donepezil | Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs) | -0.15 Pearson Product Correlation Coefficient |
p-value: 0.0225Correlation coefficient
Secondary
Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score
MMSE cognitive function: Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole using scale: 1 (poor) - 4 (excellent), possible total 13 - 52. Separate ratings from both patient and caregiver.
Time frame: baseline, 12 Weeks
Population: Intent to Treat (ITT); n=207 (number of subjects who responded)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Donepezil | Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score | 0.33 Pearson Product Correlation Coefficient |
p-value: <0.0001correlation coefficient
Secondary
Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score
MMSE cognitive function. Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver
Time frame: baseline, Week 12 LOCF
Population: Intent to Treat (ITT) LOCF: (n=231; number of subjects responding).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Donepezil | Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score | 0.35 Pearson Product Correlation Coefficient |
p-value: <0.0001correlation coefficient
Secondary
Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline
Time frame: baseline, Week 12 LOCF
Population: Intent to Treat (ITT) LOCF: (n=318; number of subjects responding)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12 | 1.1 score on scale | Standard Deviation 2.79 |
Comparison: Change from baseline in total score at Week 12 Last Observation Carried Forwardp-value: <0.0001t-test, 2 sided
Secondary
LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores
Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.
Time frame: baseline, 12 Week LOCF
Population: Intent to Treat (ITT)LOCF: (n=231; number of subjects responding)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores | 1.4 score on scale | Standard Deviation 3.44 |
p-value: <0.0001t-test, 2 sided
Secondary
LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire
EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.
Time frame: baseline, 12 Weeks LOCF
Population: Intent to Treat (ITT)LOCF: (n=318; number of subjects responding).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire | 3.1 score on scale | Standard Deviation 10.91 |
p-value: <0.0001t-test, 2 sided
Secondary
LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
EQoL-5D: measures index of health & defines it in 5 Domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each evaluated on 3-point scale yielding 243 potential combinations converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change:Week 12 mean score minus baseline mean score
Time frame: baseline, 12 Weeks LOCF
Population: Intent to Treat (ITT) LOCF: (n=321; number of subjects responding)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Donepezil | LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D) | 0.013 score on scale | Standard Deviation 0.1053 |
p-value: 0.0229t-test, 2 sided