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COMPLETEDPHASE2

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

NCT00165659•Eisai Limited

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)

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+10 more criteria

Locations (65)

Chita, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Toyohashi, Aichi-ken, Japan

Akita, Akita, Japan

Daisen, Akita, Japan

Kashiwa, Chiba, Japan

Fukui-shi, Fukui, Japan

Fukuoka, Fukuoka, Japan

Key Dates

Start Date

November 1, 2002

Primary Completion Date

May 1, 2005

Last Updated

January 29, 2010

Conditions

Alzheimer Disease

Interventions

DONEPEZIL HYDROCHLORIDE

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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