A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
Condition: Dementia With Lewy Bodies (DLB)
MeSH terms: Dementia; Lewy Body Disease
Intervention: 3 mg Donepezil hydrochloride; 5 mg Donepezil hydrochloride; 10 mg Donepezil hydrochloride; Placebo
Intervention description: 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.; 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).; 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).; 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.
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 167.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Lewy Body Disease; Dementia; Clinical Trial; Phase II; E2020; donepezil hydrochloride

Summary:

      The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with
      Dementia with Lewy Bodies (DLB).
    

Eligibility criteria:

        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.