Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
A Phase 2 Multi-center, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
1 other identifier
interventional
482
1 country
50
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2014
Typical duration for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2017
CompletedResults Posted
Study results publicly available
August 9, 2018
CompletedFebruary 26, 2019
February 1, 2019
3.2 years
March 4, 2014
May 7, 2018
February 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
ADAS-cog Change From Baseline to Week 52
The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).
Baseline and 52 weeks
CGIC
The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials.
52 weeks
Secondary Outcomes (1)
ADCS-ADL Change From Baseline to Week 52
Baseline and 52 weeks
Study Arms (3)
T-817MA-H
EXPERIMENTAL224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
T-817MA-L
EXPERIMENTAL224 mg T-817MA once daily
Placebo
PLACEBO COMPARATORPlacebo once daily
Interventions
Eligibility Criteria
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®)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
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
Related Publications (1)
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.
PMID: 31282954DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Project Manager
- Organization
- FUJIFILM Toyama Chemical
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 6, 2014
Study Start
March 1, 2014
Primary Completion
May 5, 2017
Study Completion
May 5, 2017
Last Updated
February 26, 2019
Results First Posted
August 9, 2018
Record last verified: 2019-02