Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
NCT ID: NCT02079909
Last Updated: 2019-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
482 participants
INTERVENTIONAL
2014-03-31
2017-05-05
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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T-817MA-H
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-H
224 mg or 448 mg T-817 MA once daily
T-817MA-L
224 mg T-817MA once daily
T-817MA-L
224 mg T-817 MA once daily
Placebo
Placebo once daily
Placebo
Placebo
Interventions
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T-817MA-H
224 mg or 448 mg T-817 MA once daily
T-817MA-L
224 mg T-817 MA once daily
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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®)
55 Years
85 Years
ALL
No
Sponsors
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Alzheimer's Disease Cooperative Study (ADCS)
OTHER
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
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
Boston University Alzheimer's Disease Center
Boston, Massachusetts, United States
University of Michigan Health System/ Michigan Clinical Research Unit
Ann Arbor, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Bronson Neurobehvioral Health
Paw Paw, Michigan, United States
University of Nebraska Medical Center(Geri Psych)
Omaha, Nebraska, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Global Medical Institutes, LLC;Princeton Medical Institute
Princeton, New Jersey, United States
Dent Neurologic Institute
Amherst, New York, United States
Alzheimer's Disease Research Center of Mount Sinai
New York, New York, United States
Columbia University Medical Center Sergievsky Center Taub Institute
New York, New York, United States
The Nathan S. Kline Instituite for Psychiatric Research
Orangeburg, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Wake Forest University (WFU) School of Medicine
Winston-Salem, North Carolina, United States
Case Western Reserve University/ University Hospitals Case Medical Center
Beachwood, Ohio, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, United States
Hospital at the University of Pennsylvania, Penn Memory Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh, Alzheimer Disease Research Center
Pittsburgh, Pennsylvania, United States
Abington Neurological Associates, LTD.
Willow Grove, Pennsylvania, United States
Roper St. Francis Healthcare
Charleston, South Carolina, United States
Vanderbilt University Medical Center -VUIIS
Nashville, Tennessee, United States
University of North Texas Health Science Center
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Cary J. Kohlenberg MD., SC dba IPC Research
Waukesha, Wisconsin, United States
Countries
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References
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Schneider LS, Thomas RG, Hendrix S, Rissman RA, Brewer JB, Salmon DP, Oltersdorf T, Okuda T, Feldman HH; Alzheimer's Disease Cooperative Study TCAD Study Group. Safety and Efficacy of Edonerpic Maleate for Patients With Mild to Moderate Alzheimer Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2019 Nov 1;76(11):1330-1339. doi: 10.1001/jamaneurol.2019.1868.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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T817MAUS202
Identifier Type: -
Identifier Source: org_study_id
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