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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00663936

Run by

FUJIFILM Toyama Chemical Co., Ltd.

People needed

373

Starts

2008-04-01

Expected to finish

2011-06-01

Last updated by the study team

2013-11-05

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Patients with clinically significant cardiac, hepatic or renal impairment
• Patient have a dementia not of the Alzheimer's type etc (According to the protocol)
• 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).

Where it is running

• 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
• Galiz Research — Miami Springs, Florida, United States
• Anchor Research Center — Naples, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute — Tampa, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Columbus Research & Wellness Institute — Columbus, Georgia, United States
• Agewell — Indianapolis, Indiana, United States
• Cleveland Clinic - Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States
• Comprehensive Clinical Research — Berlin, New Jersey, United States
• Memory Enhancement Center of America — Toms River, New Jersey, United States
• Brooklyn Medical Institute — Brooklyn, New York, United States
• SPRI Clinical Trials — Brooklyn, New York, United States
• Alzheimer's Disease Center, U. of Rochester Medical Center — Rochester, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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