Clinical trial NCT00543855: A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
Official title: Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia With Lewy Bodies (DLB)
Keywords: Lewy Body Disease
Dementia
Clinical Trial
Phase II
E2020
donepezil hydrochloride
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 167
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)
timeFrame: Baseline and every 4 weeks up to 12 weeks
measure: Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)
timeFrame: Baseline and every 4 weeks up to 12 weeks
measure: Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
timeFrame: Baseline and week 12
measure: Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)
timeFrame: Baseline and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Obu
country: Japan
state: Aichi
city: Toyokawa
country: Japan
state: Aichi
city: Kurume
country: Japan
state: Fukuoka
city: Omuta
country: Japan
state: Fukuoka
city: Maebashi
country: Japan
state: Gunma
city: Miyoshi
country: Japan
state: Hiroshima
city: Otake
country: Japan
state: Hiroshima
city: Himeji
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Tsukuba
country: Japan
state: Ibaraki
city: Kahoku
country: Japan
state: Ishikawa
city: Morioka
country: Japan
state: Iwate
city: Yokohama
country: Japan
state: Kanagawa
city: Nankoku
country: Japan
state: Kochi
city: Koshi
country: Japan
state: Kumamoto
city: Joyo
country: Japan
state: Kyoto
city: Sendai
country: Japan
state: Miyagi
city: Komoro
country: Japan
state: Nagano
city: Kashihara
country: Japan
state: Nara
city: Joetsu
country: Japan
state: Niigata
city: Sanjo
country: Japan
state: Niigata
city: Yufu
country: Japan
state: Oita
city: Sakai
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Izumo
country: Japan
state: Shimane
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Ube
country: Japan
state: Yamaguchi
city: Akita
country: Japan
city: Chiba
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Kochi
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
Study officials:
affiliation: Neurosciences Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System.
name: Masaki Nakagawa
role: STUDY_DIRECTOR
References: