Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
NCT00663936 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 373
Last updated 2013-11-05
Summary
The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.
Conditions
Interventions
- DRUG
-
T-817MA
224 mg T-817 MA once daily
- DRUG
-
Placebo once daily
Sponsors & Collaborators
-
FUJIFILM Toyama Chemical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2011-05-31
- Completion
- 2011-06-30
Countries
- United States
- Canada
Study Locations
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