Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00663936
Last Updated: 2013-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
373 participants
INTERVENTIONAL
2008-04-30
2011-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
T-817MA once daily
T-817MA
224 mg T-817 MA once daily
2
Placebo once daily
Placebo
Placebo once daily
Interventions
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T-817MA
224 mg T-817 MA once daily
Placebo
Placebo once daily
Eligibility Criteria
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Inclusion Criteria
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
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).
50 Years
90 Years
ALL
No
Sponsors
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FUJIFILM Toyama Chemical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
The Alzheimer's Memory Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Clinical Trials of America, Inc.
Winston-Salem, North Carolina, United States
The Clinical Trials Center
Jenkintown, Pennsylvania, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
Innovative Clinical Trials
San Antonio, Texas, United States
IPC Research
Waukesha, Wisconsin, United States
St. Joseph's Hospital
Saint John, New Brunswick, Canada
Toronto Memory Program
Toronto, Ontario, Canada
Countries
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Other Identifiers
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AA4437420
Identifier Type: -
Identifier Source: org_study_id