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

Phase 2

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: T-817MA-L
Drug: Placebo
Drug: T-817MA-H

Registration Number: NCT02079909

Lead Sponsor: FUJIFILM Toyama Chemical Co., Ltd.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 482

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T-817MA-L	T-817MA-L	224 mg T-817MA once daily
Placebo	Placebo	Placebo once daily
T-817MA-H	T-817MA-H	224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.

Primary Outcome Measures

Name	Time	Method
ADAS-cog Change From Baseline to Week 52	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).
CGIC	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.

Secondary Outcome Measures

Name	Time	Method
ADCS-ADL Change From Baseline to Week 52	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.

Trial Locations

Locations (50): Hospital at the University of Pennsylvania, Penn Memory Center
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Philadelphia, Pennsylvania, United States
Rush University Medical Center
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Chicago, Illinois, United States
University of Pittsburgh, Alzheimer Disease Research Center
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Pittsburgh, Pennsylvania, United States
Infinity Clinical Research, LLC
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Hollywood, Florida, United States
UCSD Comprehensive Alzheimer's Program
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La Jolla, California, United States
Geriatric and Adult Psychiatry, LCC
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Hamden, Connecticut, United States
Neuro Trials Research, Inc
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Atlanta, Georgia, United States
Banner Sun Health Research Institute
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Sun City, Arizona, United States
Indiana Medical Research
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Elkhart, Indiana, United States
University of Arizona Health Sciences Center
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Tucson, Arizona, United States
UC Irvine Medical Center
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Orange, California, United States
Georgetown University Clinical Research Unit
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Washington, District of Columbia, United States
Renstar Medical Research
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Ocala, Florida, United States
Pennington Biomedical Research Center
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Baton Rouge, Louisiana, United States
University of Rochester Medical Center
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Rochester, New York, United States
Boston University Alzheimer's Disease Center
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Boston, Massachusetts, United States
Banner Alzheimer's Institute
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Phoenix, Arizona, United States
University of Miami Miller-School of Medicine
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Miami, Florida, United States
Meridien Research
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Tampa, Florida, United States
University of Nebraska Medical Center(Geri Psych)
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Omaha, Nebraska, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
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Las Vegas, Nevada, United States
Houston Methodist Hospital
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Houston, Texas, United States
Neurology Center of North Orange County
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Fullerton, California, United States
Research Center for Clinical Studies, Inc.
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Norwalk, Connecticut, United States
SIU School of Medicine
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Springfield, Illinois, United States
University of Iowa Hospitals and Clinics
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Iowa City, Iowa, United States
Indiana University Health Partners, Adult Neurology Clinic
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Indianapolis, Indiana, United States
University of Kentucky Sanders-Brown Center on Aging Clinic
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Lexington, Kentucky, United States
Acadia Hospital
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Bangor, Maine, United States
Bronson Neurobehvioral Health
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Paw Paw, Michigan, United States
Global Medical Institutes, LLC;Princeton Medical Institute
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Princeton, New Jersey, United States
Alzheimer's Disease Research Center of Mount Sinai
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New York, New York, United States
Columbia University Medical Center Sergievsky Center Taub Institute
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New York, New York, United States
Dent Neurologic Institute
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Amherst, New York, United States
SUNY Upstate Medical University
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Syracuse, New York, United States
Case Western Reserve University/ University Hospitals Case Medical Center
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Beachwood, Ohio, United States
Abington Neurological Associates, LTD.
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Willow Grove, Pennsylvania, United States
Vanderbilt University Medical Center -VUIIS
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Nashville, Tennessee, United States
University of Wisconsin Hospital and Clinics
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Madison, Wisconsin, United States
University of North Texas Health Science Center
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Fort Worth, Texas, United States
The Nathan S. Kline Instituite for Psychiatric Research
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Orangeburg, New York, United States
University of Kansas/Clinical and Translational Science Unit
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Fairway, Kansas, United States
Tulsa Clinical Research, LLC
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Tulsa, Oklahoma, United States
Cary J. Kohlenberg MD., SC dba IPC Research
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Waukesha, Wisconsin, United States
Yale University, Alzheimer's Disease Research Unit
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New Haven, Connecticut, United States
University of Michigan Health System/ Michigan Clinical Research Unit
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Ann Arbor, Michigan, United States
Wake Forest University (WFU) School of Medicine
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Winston-Salem, North Carolina, United States
Roper St. Francis Healthcare
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Charleston, South Carolina, United States
Scientific Clinical Research, Inc
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North Miami, Florida, United States
Michigan State University
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East Lansing, Michigan, United States