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 safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).
Interventions
DRUGE2020
Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB. 2. Patients who have completed Phase II double-blind study (E2020-J081-431). 3. Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution.
Exclusion criteria
1. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or who underwent brain surgery causing unsolved deficiency. 2. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety. 3. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion. 4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV). 5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mini-mental State Examination (MMSE) Total | Baseline, Week 52, and Week 52 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 From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Baseline, Week 52, and Week 52 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| E2020 Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast. | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 18 |
| Overall Study | Not eligible | 1 |
| Overall Study | No treatment for 3 weeks | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Prohibited Concomitant Medication | 2 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | E2020 |
|---|---|
| Age, Continuous | 78.9 Years STANDARD_DEVIATION 5.7 |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 40 Participants |
| Weight | 49 kg STANDARD_DEVIATION 9.24 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 108 |
| serious Total, serious adverse events | 8 / 108 |
Outcome results
Primary
Change From Baseline in Mini-mental State Examination (MMSE) Total
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.
Time frame: Baseline, Week 52, and Week 52 LOCF
Population: Efficacy Analysis Set: subjects who received at least one dose of E2020 and also provided safety assessment data after baseline, with at least one available efficacy evaluation. Two subjects whose diagnosis was suspected not to meet clinical criteria of probable DLB and 2 subjects with lack of efficacy data were excluded from the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E2020 | Change From Baseline in Mini-mental State Examination (MMSE) Total | Baseline | 20.9 Score on a Scale | Standard Deviation 5.1 |
| E2020 | Change From Baseline in Mini-mental State Examination (MMSE) Total | Week 52 | 0.3 Score on a Scale | Standard Deviation 3.7 |
| E2020 | Change From Baseline in Mini-mental State Examination (MMSE) Total | Week 52 LOCF | 0.2 Score on a Scale | Standard Deviation 3.5 |
| Placebo/E2020 | Change From Baseline in Mini-mental State Examination (MMSE) Total | Baseline | 18.6 Score on a Scale | Standard Deviation 4.7 |
| Placebo/E2020 | Change From Baseline in Mini-mental State Examination (MMSE) Total | Week 52 | 2 Score on a Scale | Standard Deviation 4.4 |
| Placebo/E2020 | Change From Baseline in Mini-mental State Examination (MMSE) Total | Week 52 LOCF | 1.7 Score on a Scale | Standard Deviation 4.4 |
Primary
Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
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.
Time frame: Baseline, Week 52, and Week 52 LOCF
Population: Efficacy Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E2020 | Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Baseline | 13.1 Score on a Scale | Standard Deviation 16.8 |
| E2020 | Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Week 52 | -1.9 Score on a Scale | Standard Deviation 9.8 |
| E2020 | Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Week 52 LOCF | -0.7 Score on a Scale | Standard Deviation 11.1 |
| Placebo/E2020 | Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Baseline | 17.8 Score on a Scale | Standard Deviation 8.2 |
| Placebo/E2020 | Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Week 52 | -4.1 Score on a Scale | Standard Deviation 10.1 |
| Placebo/E2020 | Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | Week 52 LOCF | -4.3 Score on a Scale | Standard Deviation 9.7 |