Dementia With Lewy Bodies (DLB)
Conditions
Keywords
Lewy Body Disease, Dementia, Clinical Trial, Phase II, E2020, donepezil hydrochloride
Brief summary
The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB).
Interventions
DRUG3 mg Donepezil hydrochloride
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
DRUG5 mg Donepezil hydrochloride
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
DRUG10 mg Donepezil hydrochloride
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks). Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).
DRUGPlacebo
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB. Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.
Exclusion criteria
Participants with past experience of donepezil (Aricept) therapy at the same study institution. Participants treated with donepezil in 3 months immediately before starting the observation period. Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency. Participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion Participants with severe extrapyramidal disorders (Hoehn & Yahr staging score is ≥IV) Participants whose systolic blood pressure is \<90 mmHg or pulse rate is \<50 beats/min. Participants suspected to have a complication of vascular dementia based upon neurological findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline and every 4 weeks up to 12 weeks | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method. |
| Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline and every 4 weeks up to 12 weeks | NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method. |
| Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline and week 12 | CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from markedly improved to markedly worse. Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method. |
| Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline and Week 12 | J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia. ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method. |
Countries
Japan
Participant flow
Pre-assignment details
167 participants initiated the Observation period, 140 participants were enrolled in the treatment period, one participant did not receive treatment.
Participants by arm
| Arm | Count |
|---|---|
| 3 mg Donepezil Hydrochloride E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast. | 35 |
| 5 mg Donepezil Hydrochloride E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks). | 33 |
| 10 mg Donepezil Hydrochloride E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks). | 37 |
| Placebo Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast. | 34 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 3 | 4 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | 3 mg Donepezil Hydrochloride | 5 mg Donepezil Hydrochloride | 10 mg Donepezil Hydrochloride | Placebo | Total |
|---|---|---|---|---|---|
| Age Continuous | 79.6 years STANDARD_DEVIATION 4.5 | 77.9 years STANDARD_DEVIATION 6.7 | 78.4 years STANDARD_DEVIATION 6.1 | 78.7 years STANDARD_DEVIATION 4.9 | 78.7 years STANDARD_DEVIATION 5.6 |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 33 Participants | 23 Participants | 90 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 4 Participants | 11 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 24 / 35 | 27 / 33 | 32 / 37 | 24 / 34 |
| serious Total, serious adverse events | 2 / 35 | 2 / 33 | 4 / 37 | 2 / 34 |
Outcome results
Primary
Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)
J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia. ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time frame: Baseline and Week 12
Population: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mg Donepezil Hydrochloride | Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 28.3 Score on a scale | Standard Deviation 14.4 |
| 3 mg Donepezil Hydrochloride | Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | -1.3 Score on a scale | Standard Deviation 11.1 |
| 5 mg Donepezil Hydrochloride | Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | -0.6 Score on a scale | Standard Deviation 16.4 |
| 5 mg Donepezil Hydrochloride | Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 23.2 Score on a scale | Standard Deviation 11.6 |
| 10 mg Donepezil Hydrochloride | Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 26.9 Score on a scale | Standard Deviation 16.3 |
| 10 mg Donepezil Hydrochloride | Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | -5.2 Score on a scale | Standard Deviation 13.8 |
| Placebo | Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 22.3 Score on a scale | Standard Deviation 9.8 |
| Placebo | Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | 2.9 Score on a scale | Standard Deviation 9.1 |
Primary
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time frame: Baseline and every 4 weeks up to 12 weeks
Population: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mg Donepezil Hydrochloride | Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 20.1 Score on a scale | Standard Deviation 4.2 |
| 3 mg Donepezil Hydrochloride | Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | 1.2 Score on a scale | Standard Deviation 3.8 |
| 5 mg Donepezil Hydrochloride | Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | 3.5 Score on a scale | Standard Deviation 3.2 |
| 5 mg Donepezil Hydrochloride | Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 19.7 Score on a scale | Standard Deviation 4.4 |
| 10 mg Donepezil Hydrochloride | Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 19.7 Score on a scale | Standard Deviation 4.5 |
| 10 mg Donepezil Hydrochloride | Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | 2.3 Score on a scale | Standard Deviation 3.2 |
| Placebo | Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 18.2 Score on a scale | Standard Deviation 4.8 |
| Placebo | Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | -0.6 Score on a scale | Standard Deviation 2.7 |
Primary
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from markedly improved to markedly worse. Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time frame: Baseline and week 12
Population: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Marked improvement | 3.6 Percentage of Participants |
| 3 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Moderate Worsening | 0 Percentage of Participants |
| 3 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Minimal Worsening | 3.6 Percentage of Participants |
| 3 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Moderate Improvement | 17.9 Percentage of Participants |
| 3 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Marked Worsening | 3.6 Percentage of Participants |
| 3 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Minimal Improvement | 50.0 Percentage of Participants |
| 3 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | No Change | 21.4 Percentage of Participants |
| 5 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Moderate Worsening | 7.1 Percentage of Participants |
| 5 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | No Change | 14.3 Percentage of Participants |
| 5 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Minimal Improvement | 35.7 Percentage of Participants |
| 5 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Minimal Worsening | 7.1 Percentage of Participants |
| 5 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Marked Worsening | 0 Percentage of Participants |
| 5 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Moderate Improvement | 17.9 Percentage of Participants |
| 5 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Marked improvement | 17.9 Percentage of Participants |
| 10 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | No Change | 30.8 Percentage of Participants |
| 10 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Marked improvement | 3.8 Percentage of Participants |
| 10 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Moderate Improvement | 11.5 Percentage of Participants |
| 10 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Minimal Improvement | 50.0 Percentage of Participants |
| 10 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Minimal Worsening | 3.8 Percentage of Participants |
| 10 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Moderate Worsening | 0 Percentage of Participants |
| 10 mg Donepezil Hydrochloride | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Marked Worsening | 0 Percentage of Participants |
| Placebo | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Minimal Improvement | 29.6 Percentage of Participants |
| Placebo | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Marked Worsening | 0 Percentage of Participants |
| Placebo | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Moderate Worsening | 11.1 Percentage of Participants |
| Placebo | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Moderate Improvement | 3.7 Percentage of Participants |
| Placebo | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Marked improvement | 0 Percentage of Participants |
| Placebo | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | Minimal Worsening | 37.0 Percentage of Participants |
| Placebo | Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) | No Change | 18.5 Percentage of Participants |
Primary
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)
NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from 0 to 120, higher score indicated worse neuropsychiatric outcomes. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time frame: Baseline and every 4 weeks up to 12 weeks
Population: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 mg Donepezil Hydrochloride | Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 20.9 Score on a scale | Standard Deviation 13.1 |
| 3 mg Donepezil Hydrochloride | Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | -4.3 Score on a scale | Standard Deviation 21.5 |
| 5 mg Donepezil Hydrochloride | Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | -5.9 Score on a scale | Standard Deviation 6.5 |
| 5 mg Donepezil Hydrochloride | Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 14.2 Score on a scale | Standard Deviation 8.4 |
| 10 mg Donepezil Hydrochloride | Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 19.1 Score on a scale | Standard Deviation 11.8 |
| 10 mg Donepezil Hydrochloride | Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | -10.2 Score on a scale | Standard Deviation 12 |
| Placebo | Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) | Baseline | 18.4 Score on a scale | Standard Deviation 8.9 |
| Placebo | Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) | Change from Baseline (LOCF) | -3.1 Score on a scale | Standard Deviation 10.9 |