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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079909
• Other study ID #: T817MAUS202
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: May 5, 2017

Study information

• Verified date: February 2019
• Source: FUJIFILM Toyama Chemical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: May 5, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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®)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
FUJIFILM Toyama Chemical Co., Ltd.	Alzheimer's Disease Cooperative Study (ADCS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	ADCS-ADL Change From Baseline to Week 52	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

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