Clinical trial NCT01278407: A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dementia With Lewy Bodies (DLB)
Keywords: DLB
Dementia with Lewy bodies
Lewy Body Disease
Dementia
E2020
Donepezil
Aricept
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 142
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 confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

Detailed description: This 52-week study consisted of 16-week randomized placebo-controlled (RCT, including 12-week Confirmatory Phase) and 36-week open-label extension phases. Of 142 DLB patients enrolled in the RCT phase (three arms: placebo, 5 mg, and 10 mg), 110 entered the extension phase. The placebo group of the RCT phase initiated active treatment at week 16, and the active groups maintained allocated treatment and dosages until week 24. After week 24, all patients received 10 mg. Dose reduction to 5 mg for safety concerns was allowed.

Eligibility criteria: Inclusion Criteria

1. Patients diagnosed as probable dementia with Lewy bodies (DLB) according to the consensus diagnostic criteria for DLB
2. Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution
3. Clinical Dementia Rating (CDR) score ≥ 0.5
4. Mini-Mental State Examination (MMSE) score of 10 to 26

Exclusion Criteria

1. Patients diagnosed with Parkinson's disease with dementia (PDD)
2. Patients who received anti-dementia drug therapy at the same institution
3. Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
4. 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, or a history of brain surgery causing unrecovered deficiency
5. Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
6. Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening

Primary outcomes:
measure: Change From Baseline in Mini-Mental State Examination (MMSE) Score
timeFrame: Week 12 for Confirmatory Phase
measure: Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score
timeFrame: Week 12 for Confirmatory Phase
Secondary outcomes:
Other outcomes:
Locations:
city: Anjo-shi
country: Japan
state: Aichi
city: Nagoya-shi
country: Japan
state: Aichi
city: Toyokawa-shi
country: Japan
state: Aichi
city: Chiba-shi
country: Japan
state: Chiba
city: Fukui-shi
country: Japan
state: Fukui
city: Yoshida-gun
country: Japan
state: Fukui
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Kitakyushu-shi
country: Japan
state: Fukuoka
city: Omuta-shi
country: Japan
state: Fukuoka
city: Gifu-shi
country: Japan
state: Gifu
city: Mizunami-shi
country: Japan
state: Gifu
city: Fujioka-shi
country: Japan
state: Gunma
city: Maebashi-shi
country: Japan
state: Gunma
city: Kure-shi
country: Japan
state: Hiroshima
city: Miyoshi-shi
country: Japan
state: Hiroshima
city: Otake-shi
country: Japan
state: Hiroshima
city: Obihiro-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Himeji-shi
country: Japan
state: Hyogo
city: Kobe-shi
country: Japan
state: Hyogo
city: Yabu-shi
country: Japan
state: Hyogo
city: Bando-shi
country: Japan
state: Ibaraki
city: Hitachi-shi
country: Japan
state: Ibaraki
city: Kahoku-shi
country: Japan
state: Ishikawa
city: Morioka-shi
country: Japan
state: Iwate
city: Fujisawa-shi
country: Japan
state: Kanagawa
city: Kochi-shi
country: Japan
state: Kochi
city: Koshi-shi
country: Japan
state: Kumamoto
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Uji-shi
country: Japan
state: Kyoto
city: Sendai-shi
country: Japan
state: Miyagi
city: Higashimorokata-gun
country: Japan
state: Miyazaki
city: Ina-shi
country: Japan
state: Nagano
city: Kitaazumi-gun
country: Japan
state: Nagano
city: Matsumoto-shi
country: Japan
state: Nagano
city: Nishisonogi-gun
country: Japan
state: Nagasaki
city: Nagaoka-shi
country: Japan
state: Niigata
city: Sanjo-shi
country: Japan
state: Niigata
city: Tsubame-shi
country: Japan
state: Niigata
city: Yufu-shi
country: Japan
state: Oita
city: Osaka-shi
country: Japan
state: Osaka
city: Sakai-shi
country: Japan
state: Osaka
city: Sennan-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Ageo-shi
country: Japan
state: Saitama
city: Kasukabe-shi
country: Japan
state: Saitama
city: Saitama-shi
country: Japan
state: Saitama
city: Fuji-shi
country: Japan
state: Shizuoka
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Shizuoka-shi
country: Japan
state: Shizuoka
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: Suginami-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Neuroscience Clinical Development Section. JAC PCU
name: Masaki Nakagawa
role: STUDY_DIRECTOR
References:
citation: Mori E, Ikeda M, Nagai R, Matsuo K, Nakagawa M, Kosaka K. Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial. Alzheimers Res Ther. 2015 Feb 3;7(1):5. doi: 10.1186/s13195-014-0081-2. eCollection 2015.
citation: Ikeda M, Mori E, Matsuo K, Nakagawa M, Kosaka K. Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled, confirmatory phase III trial. Alzheimers Res Ther. 2015 Feb 3;7(1):4. doi: 10.1186/s13195-014-0083-0. eCollection 2015.