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Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease

A Phase 2a Multi-center, Randomized, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of T-817MAa in Patients With Mild to Moderate Alzheimer's Disease

NCT00663936•FUJIFILM Toyama Chemical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female (post-menopausal or surgically sterile)
•2. Patients with Mild to moderate Alzheimer's disease who are receiving Donepezil.
•3. Age 50 to 90 inclusive
•4. Patients must be living in the community
•5. Patients must have an eligible informant or study partner (caregiver)
•6. Patients and eligible informant or study partner (caregiver) must be able to read and understand English.
•7. Informed consent obtained from both the patient and the caregiver etc (According to the protocol)

Exclusion Criteria

•1. Patients with clinically significant cardiac, hepatic or renal impairment
•2. Patient have a dementia not of the Alzheimer's type etc (According to the protocol)
•3. Patients who are taking any drug other than donepezil for Alzheimer's disease, including rivastigmine (Exelon®), galantamine (Razadyne®), memantine (Namenda™) or tacrine (Cognex®) taken within twelve (12) weeks of the Baseline Visit (Visit 2).

Locations (35)

Banner Alzheimer's Institute

Phoenix, Arizona, United States

Northwest NeuroSpecialists

Tucson, Arizona, United States

Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

Southwest Institute for Clinical Research, Inc.

Rancho Mirage, California, United States

Pacific Research Network, Inc.

San Diego, California, United States

San Francisco Clinical Research Center

San Francisco, California, United States

Radiant Research

Denver, Colorado, United States

Geriatric and Adult Psychiatry, LCC

Hamden, Connecticut, United States

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, United States

NeuroPsychiatric Center of the Palm Beaches

Boynton Beach, Florida, United States

Key Dates

Start Date

April 1, 2008

Primary Completion Date

May 1, 2011

Completion Date

June 1, 2011

Last Updated

November 5, 2013

Enrollment

373

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

T-817MA

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

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: November 5, 2013Data 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

Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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