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A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00543855
First received: October 4, 2007
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Dementia With Lewy Bodies (DLB)
Drug: 3 mg Donepezil hydrochloride
Drug: 5 mg Donepezil hydrochloride
Drug: 10 mg Donepezil hydrochloride
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and every 4 weeks up to 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

    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.



Enrollment: 167
Study Start Date: November 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3 mg Donepezil hydrochloride Drug: 3 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.

Other Names:
  • Aricept
  • Donepezil hydrochloride
  • E2020
Experimental: 5 mg Donepezil hydrochloride Drug: 5 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).

Other Names:
  • Aricept
  • Donepezil hydrochloride
  • E2020
Experimental: 10 mg Donepezil hydrochloride Drug: 10 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).

Other Names:
  • Aricept
  • Donepezil hydrochloride
  • E2020
Placebo Comparator: Placebo Drug: 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.


  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543855

Locations
Japan
Nagoya, Aichi, Japan
Obu, Aichi, Japan
Toyokawa, Aichi, Japan
Kurume, Fukuoka, Japan
Omuta, Fukuoka, Japan
Maebashi, Gunma, Japan
Miyoshi, Hiroshima, Japan
Otake, Hiroshima, Japan
Himeji, Hyogo, Japan
Kobe, Hyogo, Japan
Tsukuba, Ibaraki, Japan
Kahoku, Ishikawa, Japan
Morioka, Iwate, Japan
Yokohama, Kanagawa, Japan
Nankoku, Kochi, Japan
Koshi, Kumamoto, Japan
Joyo, Kyoto, Japan
Sendai, Miyagi, Japan
Komoro, Nagano, Japan
Kashihara, Nara, Japan
Joetsu, Niigata, Japan
Sanjo, Niigata, Japan
Yufu, Oita, Japan
Sakai, Osaka, Japan
Suita, Osaka, Japan
Izumo, Shimane, Japan
Bunkyo-ku, Tokyo, Japan
Kodaira, Tokyo, Japan
Koto-ku, Tokyo, Japan
Ota-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Ube, Yamaguchi, Japan
Akita, Japan
Chiba, Japan
Fukui, Japan
Fukuoka, Japan
Kochi, Japan
Kumamoto, Japan
Kyoto, Japan
Osaka, Japan
Saitama, Japan
Shizuoka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Masaki Nakagawa Neurosciences Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00543855     History of Changes
Other Study ID Numbers: E2020-J081-431
Study First Received: October 4, 2007
Results First Received: January 16, 2013
Last Updated: March 5, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Lewy Body Disease
Dementia
Clinical Trial
Phase II
E2020
donepezil hydrochloride

Additional relevant MeSH terms:
Dementia
Lewy Body Disease
Delirium, Dementia, Amnestic, Cognitive Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014