Alzheimer Disease
Conditions
Keywords
non-interventional, mild to moderate Alzheimer's, ARICEPT.
Brief summary
This study assessed the Hr QoL (Health related Quality of life) of subjects with mild to moderate AD, who received ARICEPT under usual clinical practice.
Detailed description
This non-interventional study enrolled patients with mild to moderate dementia of the Alzheimer's type, who have been prescribed treatment with ARICEPT under usual clinical practice.
Interventions
OTHERNo intervention
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Alzheimer's Disease
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | Baseline, Week 12. | CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse. |
| Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | Baseline, Week 12. | The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question 'compared to the severity of your relative's condition at baseline, how much do you feel it has changed?'. |
| Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Baseline, Week 12. | QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 \[poor\] to 4 \[excellent\]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life. |
| Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Baseline, Week 12. | QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 \[poor\] to 4 \[excellent\]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT | Week 12. | — |
| Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | Baseline to Week 12. | The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable. |
| Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | Baseline to Week 12. | The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ARICEPT ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD. | 603 |
| Total | 603 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 15 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Other | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | ARICEPT |
|---|---|
| Age, Customized 18 to 44 years | 6 participants |
| Age, Customized 45 to 64 years | 44 participants |
| Age, Customized 65 years or older | 543 participants |
| Age, Customized Unspecified | 10 participants |
| Medical History Abnormal behaviour | 2 participants |
| Medical History Anaemia | 4 participants |
| Medical History Anxiety disorder | 3 participants |
| Medical History Aortic valve incompetence | 1 participants |
| Medical History Arrhythmia | 1 participants |
| Medical History Arterial disorder | 1 participants |
| Medical History Arthritis | 2 participants |
| Medical History Arthropathy | 1 participants |
| Medical History Asthma | 4 participants |
| Medical History Atrial fibrillation | 7 participants |
| Medical History Benign prostatic hyperplasia | 9 participants |
| Medical History Bipolar disorder | 1 participants |
| Medical History Cardiac failure | 1 participants |
| Medical History Cardiac operation | 1 participants |
| Medical History Cardiac pacemaker insertion | 1 participants |
| Medical History Carotid artery disease | 1 participants |
| Medical History Cataract | 4 participants |
| Medical History Cerebral ischaemia | 51 participants |
| Medical History Cerebrovascular accident | 16 participants |
| Medical History Chronic obstructive pulmonary disease | 13 participants |
| Medical History Colitis | 1 participants |
| Medical History Coronary artery disease | 64 participants |
| Medical History Dementia | 2 participants |
| Medical History Depression | 116 participants |
| Medical History Diabetes mellitus | 89 participants |
| Medical History Diabetic neuropathy | 1 participants |
| Medical History Diverticulum | 1 participants |
| Medical History Diverticulum intestinal | 1 participants |
| Medical History Dyslipidaemia | 1 participants |
| Medical History Dystonia | 1 participants |
| Medical History Epilepsy | 7 participants |
| Medical History Erysipelas | 1 participants |
| Medical History Extrapyramidal disorder | 3 participants |
| Medical History Eye disorder | 1 participants |
| Medical History Gastrooesophageal reflux disease | 3 participants |
| Medical History Glaucoma | 1 participants |
| Medical History Glomerulonephritis | 1 participants |
| Medical History Goitre | 3 participants |
| Medical History Haemangioma | 1 participants |
| Medical History Headache | 1 participants |
| Medical History Hypercholesterolaemia | 2 participants |
| Medical History Hyperlipidaemia | 129 participants |
| Medical History Hypertension | 273 participants |
| Medical History Hyperthyroidism | 7 participants |
| Medical History Hyperuricaemia | 3 participants |
| Medical History Hypothyroidism | 16 participants |
| Medical History Incontinence | 1 participants |
| Medical History Iron deficiency anaemia | 3 participants |
| Medical History Lichen sclerosus | 1 participants |
| Medical History Migraine | 2 participants |
| Medical History Motor neurone disease | 1 participants |
| Medical History Multiple sclerosis | 2 participants |
| Medical History Musculoskeletal pain | 1 participants |
| Medical History Myasthenia gravis | 1 participants |
| Medical History Necrosis | 1 participants |
| Medical History Neurosis | 2 participants |
| Medical History Oesophageal operation | 1 participants |
| Medical History Osteoarthritis | 4 participants |
| Medical History Osteoporosis | 33 participants |
| Medical History Pancreatitis chronic | 1 participants |
| Medical History Panencephalitis | 1 participants |
| Medical History Parkinson's disease | 16 participants |
| Medical History Personality change due to a general medical condit | 1 participants |
| Medical History Phobia | 1 participants |
| Medical History Polyneuropathy | 2 participants |
| Medical History Prostate cancer | 3 participants |
| Medical History Prostatic disorder | 1 participants |
| Medical History Prostatomegaly | 9 participants |
| Medical History Psychotic disorder | 3 participants |
| Medical History Psychotic disorder due to a general medical condit | 2 participants |
| Medical History Renal failure | 1 participants |
| Medical History Renal failure chronic | 2 participants |
| Medical History Rheumatoid arthritis | 3 participants |
| Medical History Sarcoidosis | 1 participants |
| Medical History Schizophrenia | 11 participants |
| Medical History Schizophrenia, paranoid type | 1 participants |
| Medical History Sciatica | 2 participants |
| Medical History Sleep disorder | 3 participants |
| Medical History Stress | 2 participants |
| Medical History Temporal arteritis | 1 participants |
| Medical History Thalassaemia trait | 1 participants |
| Medical History Traumatic brain injury | 1 participants |
| Medical History Tremor | 1 participants |
| Medical History Urinary incontinence | 2 participants |
| Medical History Urinary retention | 1 participants |
| Medical History Varicose vein | 1 participants |
| Medical History Venous insufficiency | 1 participants |
| Medical History Vertigo | 4 participants |
| Medical History Vitamin B12 decreased | 1 participants |
| Sex/Gender, Customized Female | 364 participants |
| Sex/Gender, Customized Male | 238 participants |
| Sex/Gender, Customized Unspecified | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / 603 |
| serious Total, serious adverse events | 2 / 603 |
Outcome results
Primary
Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 \[poor\] to 4 \[excellent\]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.
Time frame: Baseline, Week 12.
Population: FAS; (n)=number of participants evaluable at baseline and Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Physical health | 0.1 scores on a scale | Standard Deviation 0.54 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Energy | 0.2 scores on a scale | Standard Deviation 0.65 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Mood | 0.3 scores on a scale | Standard Deviation 0.72 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Living situation | 0.2 scores on a scale | Standard Deviation 0.62 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Memory | 0.3 scores on a scale | Standard Deviation 0.67 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Family | 0.1 scores on a scale | Standard Deviation 0.52 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Marriage | 0.1 scores on a scale | Standard Deviation 0.58 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Friends | 0.1 scores on a scale | Standard Deviation 0.63 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Self as a whole | 0.1 scores on a scale | Standard Deviation 0.63 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Ability to do chores around the house | 0.2 scores on a scale | Standard Deviation 0.66 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Ability to do things for fun | 0.2 scores on a scale | Standard Deviation 0.66 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Money | 0.1 scores on a scale | Standard Deviation 0.62 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Life as a whole | 0.1 scores on a scale | Standard Deviation 0.53 |
| ARICEPT | Change From Baseline in the Caregiver's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Overall score | 2.0 scores on a scale | Standard Deviation 4.58 |
Comparison: The effect of possible prognostic factors on response: primary diagnosis severity.p-value: 0.0137Regression, Linear
Comparison: The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by caregiver.p-value: <0.0001Regression, Linear
Comparison: The effect of possible prognostic factors on response: center number.p-value: <0.0001Regression, Linear
Primary
Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12
QoL-AD was comprised of 13 individual items, each measured on a 4-point Likert scale (ranging from 1 \[poor\] to 4 \[excellent\]). Overall QoL-AD score was the sum of the scores for the 13 individual items and ranged from 13 to 52, with higher scores indicating a higher health related quality of life.
Time frame: Baseline, Week 12.
Population: FAS; (n)=number of participants evaluable at baseline and Week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Physical health | 0.1 scores on a scale | Standard Deviation 0.51 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Energy | 0.2 scores on a scale | Standard Deviation 0.58 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Mood | 0.3 scores on a scale | Standard Deviation 0.7 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Living situation | 0.2 scores on a scale | Standard Deviation 0.58 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Memory | 0.3 scores on a scale | Standard Deviation 0.61 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Family | 0.1 scores on a scale | Standard Deviation 0.56 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Marriage | 0.1 scores on a scale | Standard Deviation 0.55 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Friends | 0.1 scores on a scale | Standard Deviation 0.63 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Self as a whole | 0.1 scores on a scale | Standard Deviation 0.57 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Ability to do chores around the house | 0.2 scores on a scale | Standard Deviation 0.69 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Ability to do things for fun | 0.3 scores on a scale | Standard Deviation 0.63 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Money | 0.1 scores on a scale | Standard Deviation 0.57 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Life as a whole | 0.2 scores on a scale | Standard Deviation 0.59 |
| ARICEPT | Change From Baseline in the Participant's Assessment for Quality of Life for Alzheimer's Dementia (QoL-AD) Overall and Subscale Scores at Week 12 | Overall score | 2.3 scores on a scale | Standard Deviation 4.33 |
Comparison: The effect of possible prognostic factors on response: primary diagnosis severity.p-value: 0.1805Regression, Linear
Comparison: The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by participant.p-value: <0.0001Regression, Linear
Comparison: The effect of possible prognostic factors on response: center number.p-value: <0.0001Regression, Linear
Primary
Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12
CGI-I is a 7-point physician rated scale ranging from very much improved to very much worse.
Time frame: Baseline, Week 12.
Population: Full Analysis Set (FAS): all enrolled participants who received at least 1 dose (including partial doses) of ARICEPT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARICEPT | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | Missing | 26 participants |
| ARICEPT | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | Not assessed | 5 participants |
| ARICEPT | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | Very much improved | 27 participants |
| ARICEPT | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | Much improved | 103 participants |
| ARICEPT | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | Minimally improved | 277 participants |
| ARICEPT | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | No change | 142 participants |
| ARICEPT | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | Minimally worse | 20 participants |
| ARICEPT | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | Much worse | 3 participants |
| ARICEPT | Number of Participants for Change From Baseline for Clinical Global Impressions of Improvement (CGI-I) at Week 12 | Very much worse | 0 participants |
Comparison: The effect of possible prognostic factors response on response rate: primary diagnosis severity. Participants were classified as responders if they were very much improved or much improved from baseline.p-value: 0.0023Regression, Logistic
Primary
Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12
The caregiver's assessment improvement was a 5-point rated scale ranging from much improved to much worse to the question 'compared to the severity of your relative's condition at baseline, how much do you feel it has changed?'.
Time frame: Baseline, Week 12.
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARICEPT | Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | Missing | 39 participants |
| ARICEPT | Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | Much improved | 54 participants |
| ARICEPT | Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | Improved | 343 participants |
| ARICEPT | Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | No change | 140 participants |
| ARICEPT | Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | Worse | 27 participants |
| ARICEPT | Number of Participants for Change From Baseline for the Caregiver's Assessment of Improvement at Week 12 | Much worse | 0 participants |
Comparison: The effect of possible prognostic factors on response: significant medical history. Participants were classified as responders if they were much improved or improved from baseline.p-value: 0.0382Regression, Logistic
Secondary
Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT
Time frame: Week 12.
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARICEPT | Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT | Missing | 8 participants |
| ARICEPT | Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT | 5 mg | 193 participants |
| ARICEPT | Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT | 10 mg | 400 participants |
| ARICEPT | Change in ARICEPT Dosing: Number of Participants at Each Final Dose of ARICEPT | greater than 10 mg | 2 participants |
Secondary
Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation
The starting dose of ARICPET was 5 mg once daily (QD), which could be increased to 10 mg QD during the study.
Time frame: Baseline to Week 12.
Population: FAS. Starting dose of ARICEPT was not summarized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARICEPT | Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | Missing | 198 participants |
| ARICEPT | Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | 0 weeks up to less than 4 weeks | 77 participants |
| ARICEPT | Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | 4 weeks up to less than 6 weeks | 267 participants |
| ARICEPT | Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | 6 weeks up to less than 8 weeks | 19 participants |
| ARICEPT | Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | 8 weeks up to less than 10 weeks | 13 participants |
| ARICEPT | Change in ARICEPT Dosing: Number of Participants for Time to First ARICEPT Dose Escalation | 10 weeks or later | 29 participants |
Secondary
Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12
The physician rated tolerance to ARICEPT as very good, good, adequate, unsatisfactory, or unevaluable.
Time frame: Baseline to Week 12.
Population: FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARICEPT | Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | Unevaluable | 8 participants |
| ARICEPT | Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | Missing | 9 participants |
| ARICEPT | Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | Very good | 386 participants |
| ARICEPT | Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | Good | 161 participants |
| ARICEPT | Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | Adequate | 26 participants |
| ARICEPT | Number of Participants for the Physician's Assessment of Tolerance to ARICEPT at Week 12 | Unstatisfactory | 13 participants |