A Multi-Center, Randomized, Double-Blind, Parallel Group Study With 3 Groups Receiving Placebo, 5 mg of E2020 and 10 mg of E2020

NCT ID: NCT00165659

Last Updated: 2010-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30

Brief Summary

To evaluate the dose-response efficacy of E2020 (5 mg/day and 10 mg/day) versus placebo and verify superiority of E2020 to placebo in patients with severe AD using CIBIC-plus* and SIB** as the primary efficacy measures. Safety of E2020 will also be evaluated.

(*for overall evalution of clinical symtoms) (**for cognitive function test)

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

DONEPEZIL HYDROCHLORIDE

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with diagnostics of Alzheimer's disease (AD) according to DSM-IV.
• Patients with modified Hachinski Ischemic scale score of ≦6.
• FAST score of ≧6 at baseline (4 weeks before starting study treatment).
• MMSE score between 1 and 12 at baseline (4 weeks before starting study treatment).
• Imaging diagnostics (CT, MRI, etc., within 24 months consistent with the diagnosis of AD without any other comorbid pathologies found. If a significant change in clinical status suggesting other types of dementia (except AD) is suspected between the final image diagnosis and the time of starting observation, the scan test should be repeated.
• Patients who can comply with the requirements on concomitant drugs/therapies from the baseline phase or before.
• Patients aged 50 years or older.
• Outpatients. Even in the case of an outpatient or a patient attending on the outpatient-visit basis from a nursing home facility, the caregiver must be a constant and reliable informant with minimum of 3 days per week direct contact with the patient (for at least 4 hours per day on waking hours). This contact is necessary to ensure accurate reporting of the patient's behavior and his/her ability to perform ADLs.
• Patients who are expected to complete all procedures scheduled during the Screening and Baseline visit and who have a reliable caregiver or family member who agrees to accompany the patient to all clinic visits, provide information about the patient as required by the protocol, and ensure compliance with the treatment schedule.
• Patients who can swallow tablets without pulverization.
• Patients who are ambulatory at least aided (walker) and have vision and hearing necessary for compliance with testing procedures (eyeglasses and/or hearing aid permissible).
• Patients whose representatives can sign the written informed consent.

Exclusion Criteria

• Patients with dementia other than AD.

1. Patient whose imaging test shows "circumscribed cerebral lesion or multiple infarcts" which is suspected to be the responsible cause of dementia (mixed-type dementia)

2. Patients with other types of dementia

• Patients with a current DSM-IV diagnosis of major depressive disorder or any current serious psychiatric diagnosis othe than AD.
• Patients without a reliable caregiver.
• Patients who are expected to enter a nursing home facility within 6 months after starting study treatment (excluding a transient entry).
• Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of study drugs (e.g., inflammatory bowel disease, gastric or duodenal ulcers, or severe lactose intolerance).
• Patients with a known hypersensitivity to a component of donepezil hydrochloride preparation or piperidine derivatives.
• Patients complicated with a severe gastrointestinal, hepatic, renal, endocrine, or cardiovascular system disease (e.g., sick sinus syndrome, intraarterial and supraventricular conduction disorder, etc.).
• Patients with a history of severe bronchial asthma or obstructive pulmonary disease.
• Patients with a severe extrapyramidal disease (Parkinson's disease, Parkinson's syndrome, etc.).
• Patients with diabetes mellitus with uncontrolled blood glucose levels (HbAlc of ≧10%).
• Hypertension patients with uncontrolled blood pressure (diastolic blood pressure of ≧95 mmHg).
• Patients with uncontrolled thyroid dysfunction.
• Patients with a history of seizure or convulsion within the previous 3 months (obtaining informed consent).
• Patients with a known or suspected history of alcohoism or drug dependence within the recent 10 years.
• Patients with malignant tumors.
• Women of pregnant, possibly pregnant, or lactating.
• Patients who have participated in another clinical study within the recent 3 months (before giving consent).
• Any other patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: lead

Principal Investigators

Itaru Arimoto

Role: STUDY_DIRECTOR

Eisai Co., Ltd - Development Clinical Research Dept., Clinical Research Center

Locations

Chita, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Toyohashi, Aichi-ken, Japan

Akita, Akita, Japan

Akita, Akita, Japan

Daisen, Akita, Japan

Kashiwa, Chiba, Japan

Fukui-shi, Fukui, Japan

Fukuoka, Fukuoka, Japan

Fukuoka, Fukuoka, Japan

Fukuoka, Fukuoka, Japan

Fukuoka, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Fukushima, Fukushima, Japan

Kōriyama, Fukushima, Japan

Fujioka, Gunma, Japan

Numata, Gunma, Japan

Hiroshima, Hiroshima, Japan

Hiroshima, Hiroshima, Japan

Ōtake, Hiroshima, Japan

Asahikawa, Hokkaido-prefecture, Japan

Aio, Hyōgo, Japan

Asago, Hyōgo, Japan

Kako, Hyōgo, Japan

Kobe, Hyōgo, Japan

Kobe, Hyōgo, Japan

Tsuchiura, Ibaraki, Japan

Tsukuba, Ibaraki, Japan

Kanazawa, Ishikawa-ken, Japan

Kawasaki, Kanagawa, Japan

Kawasaki, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Kochi, Kochi, Japan

Kyoto, Kyoto, Japan

Kyoto, Kyoto, Japan

Nagasaki, Nagasaki, Japan

Nagasaki, Nagasaki, Japan

Sasebo, Nagasaki, Japan

Kashihara, Nara, Japan

Jōetsu, Niigata, Japan

Kashiwazaki, Niigata, Japan

Tsukubo, Okayama-ken, Japan

Moriguchi, Osaka, Japan

Neyagawa, Osaka, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Suita, Osaka, Japan

Takatsuki, Osaka, Japan

Saitama, Saitama, Japan

Izumo, Shimane, Japan

Shizuoka, Shizuoka, Japan

Kawachi, Tochigi, Japan

Shimotsuga, Tochigi, Japan

Chiyoda-ku, Tokyo, Japan

Hachiōji, Tokyo, Japan

Higashimurayama, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Kodaira, Tokyo, Japan

Machida, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Nanto, Toyama, Japan

Gobō, Wakayama, Japan

Wakayama, Wakayama, Japan

Hōfu, Yamaguchi, Japan

Countries

Japan

Other Identifiers

E2020-J081-231

Identifier Type: -

Identifier Source: org_study_id