- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02079909
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
February 12, 2019 updated by: FUJIFILM Toyama Chemical Co., Ltd.
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
482
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States
- Banner Alzheimer's Institute
-
Sun City, Arizona, United States
- Banner Sun Health Research Institute
-
Tucson, Arizona, United States
- University of Arizona Health Sciences Center
-
-
California
-
Fullerton, California, United States
- Neurology Center of North Orange County
-
La Jolla, California, United States
- UCSD Comprehensive Alzheimer's Program
-
Orange, California, United States
- UC Irvine Medical Center
-
-
Connecticut
-
Hamden, Connecticut, United States
- Geriatric and Adult Psychiatry, LCC
-
New Haven, Connecticut, United States
- Yale University, Alzheimer's Disease Research Unit
-
Norwalk, Connecticut, United States
- Research Center for Clinical Studies, Inc.
-
-
District of Columbia
-
Washington, District of Columbia, United States
- Georgetown University Clinical Research Unit
-
-
Florida
-
Hollywood, Florida, United States
- Infinity Clinical Research, LLC
-
Miami, Florida, United States
- University of Miami Miller-School of Medicine
-
North Miami, Florida, United States
- Scientific Clinical Research, Inc
-
Ocala, Florida, United States
- Renstar Medical Research
-
Tampa, Florida, United States
- Meridien Research
-
-
Georgia
-
Atlanta, Georgia, United States
- Neuro Trials Research, Inc
-
-
Illinois
-
Chicago, Illinois, United States
- Rush University Medical Center
-
Springfield, Illinois, United States
- SIU School of Medicine
-
-
Indiana
-
Elkhart, Indiana, United States
- Indiana Medical Research
-
Indianapolis, Indiana, United States
- Indiana University Health Partners, Adult Neurology Clinic
-
-
Iowa
-
Iowa City, Iowa, United States
- University of Iowa Hospitals and Clinics
-
-
Kansas
-
Fairway, Kansas, United States
- University of Kansas/Clinical and Translational Science Unit
-
-
Kentucky
-
Lexington, Kentucky, United States
- University of Kentucky Sanders-Brown Center on Aging Clinic
-
-
Louisiana
-
Baton Rouge, Louisiana, United States
- Pennington Biomedical Research Center
-
-
Maine
-
Bangor, Maine, United States
- Acadia Hospital
-
-
Massachusetts
-
Boston, Massachusetts, United States
- Boston University Alzheimer's Disease Center
-
-
Michigan
-
Ann Arbor, Michigan, United States
- University of Michigan Health System/ Michigan Clinical Research Unit
-
East Lansing, Michigan, United States
- Michigan State University
-
Paw Paw, Michigan, United States
- Bronson Neurobehvioral Health
-
-
Nebraska
-
Omaha, Nebraska, United States
- University of Nebraska Medical Center(Geri Psych)
-
-
Nevada
-
Las Vegas, Nevada, United States
- Cleveland Clinic Lou Ruvo Center for Brain Health
-
-
New Jersey
-
Princeton, New Jersey, United States
- Global Medical Institutes, LLC;Princeton Medical Institute
-
-
New York
-
Amherst, New York, United States
- Dent Neurologic Institute
-
New York, 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
-
Orangeburg, New York, United States
- The Nathan S. Kline Instituite for Psychiatric Research
-
Rochester, New York, United States
- University of Rochester Medical Center
-
Syracuse, New York, United States
- SUNY Upstate Medical University
-
-
North Carolina
-
Winston-Salem, North Carolina, United States
- Wake Forest University (WFU) School of Medicine
-
-
Ohio
-
Beachwood, Ohio, United States
- Case Western Reserve University/ University Hospitals Case Medical Center
-
-
Oklahoma
-
Tulsa, Oklahoma, United States
- Tulsa Clinical Research, LLC
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States
- Hospital at the University of Pennsylvania, Penn Memory Center
-
Pittsburgh, Pennsylvania, United States
- University of Pittsburgh, Alzheimer Disease Research Center
-
Willow Grove, Pennsylvania, United States
- Abington Neurological Associates, Ltd.
-
-
South Carolina
-
Charleston, South Carolina, United States
- Roper St. Francis Healthcare
-
-
Tennessee
-
Nashville, Tennessee, United States
- Vanderbilt University Medical Center -VUIIS
-
-
Texas
-
Fort Worth, Texas, United States
- University of North Texas Health Science Center
-
Houston, Texas, United States
- Houston Methodist Hospital
-
-
Wisconsin
-
Madison, Wisconsin, United States
- University of Wisconsin Hospital and Clinics
-
Waukesha, Wisconsin, United States
- Cary J. Kohlenberg MD., SC dba IPC Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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®)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo once daily
|
Placebo
|
Experimental: T-817MA-H
224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.
|
224 mg or 448 mg T-817 MA once daily
|
Experimental: T-817MA-L
224 mg T-817MA once daily
|
224 mg T-817 MA once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADAS-cog Change From Baseline to Week 52
Time Frame: Baseline and 52 weeks
|
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
Time Frame: 52 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADCS-ADL Change From Baseline to Week 52
Time Frame: Baseline and 52 weeks
|
The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner.
The scale has a range of 0 to 78, with lower scores indicating greater impairment.
|
Baseline and 52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
May 5, 2017
Study Completion (Actual)
May 5, 2017
Study Registration Dates
First Submitted
March 4, 2014
First Submitted That Met QC Criteria
March 4, 2014
First Posted (Estimate)
March 6, 2014
Study Record Updates
Last Update Posted (Actual)
February 26, 2019
Last Update Submitted That Met QC Criteria
February 12, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T817MAUS202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer's Disease
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedTerminatedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
University of Southern CaliforniaAlzheimer's Therapeutic Research Institute; American Heart Association; Schaeffer...RecruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Brigham and Women's Hospital and other collaboratorsActive, not recruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedTerminatedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Alzheimer's Clinical Trials Consortium (ACTC)Enrolling by invitationPreclinical Alzheimer's Disease | Early Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease | Normal CognitionUnited States
-
University Hospital, BordeauxMinistry for Health and Solidarity, FranceCompletedAlzheimer's Disease (AD) | Alzheimer's Disease (AD) Related DisordersFrance
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States