Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC. The secondary objectives are: * To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events. * To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).

Key facts

Study ID

NCT02079909

Run by

FUJIFILM Toyama Chemical Co., Ltd.

People needed

482

Starts

2014-03-01

Expected to finish

2017-05-05

Last updated by the study team

2019-02-26

Who can join

Age: 55 and older, up to 85. 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 (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®) is allowed only when prescribed in combination with donepezil or rivastigmine transdermal system.
• Age 55 to 85 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

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 or rivastigmine transdermal system for Alzheimer's disease, including olal rivastigmine (Exelon®), galantamine (Razadyne®)

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Banner Sun Health Research Institute — Sun City, Arizona, United States
• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• UCSD Comprehensive Alzheimer's Program — La Jolla, California, United States
• UC Irvine Medical Center — Orange, California, United States
• Geriatric and Adult Psychiatry, LCC — Hamden, Connecticut, United States
• Yale University, Alzheimer's Disease Research Unit — New Haven, Connecticut, United States
• Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
• Georgetown University Clinical Research Unit — Washington D.C., District of Columbia, United States
• Infinity Clinical Research, LLC — Hollywood, Florida, United States
• University of Miami Miller-School of Medicine — Miami, Florida, United States
• Scientific Clinical Research, Inc — North Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Neuro Trials Research, Inc — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• SIU School of Medicine — Springfield, Illinois, United States
• Indiana Medical Research — Elkhart, Indiana, United States
• Indiana University Health Partners, Adult Neurology Clinic — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas/Clinical and Translational Science Unit — Fairway, Kansas, United States
• University of Kentucky Sanders-Brown Center on Aging Clinic — Lexington, Kentucky, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Acadia Hospital — Bangor, Maine, United States

Full record on ClinicalTrials.gov

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