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

NCT00165659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2010-01-29

No results posted yet for this study

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

Interventions

DRUG

DONEPEZIL HYDROCHLORIDE

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Principal Investigators

  • Itaru Arimoto · Eisai Co., Ltd - Development Clinical Research Dept., Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2005-05-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00165659 on ClinicalTrials.gov