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NOBLE: T-817MA for Mild to Moderate Alzheimer's Disease

Completed

This Phase II study will evaluate the efficacy of the experimental drug T-817MA as a possible treatment for people with mild to moderate Alzheimer's disease. Its impact on cognition and daily functioning will be measured by standard tests.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 85 Years Both No
March 2014
May 5, 2017
450

  • Diagnosis of mild to moderate Alzheimer's disease
  • Taking the medication donepezil (Aricept) or rivastigmine transdermal system (Exelon patch); memantine (Namenda) is allowed only when prescribed in combination with donepezil or the rivastigmine transdermal system
  • Living in the community
  • Study partner or caregiver who has regular contact with participant (at least 10 hours per week) and can accompany his/her to study visits
  • Participant and caregiver able to read and understand English
  • Female participants must be postmenopausal or surgically sterile

  • Clinically significant cardiac, hepatic, or renal impairment
  • Non-Alzheimer's dementia (for example, vascular dementia, frontotemporal disorder, Lewy body dementia)
  • Taking any drug for Alzheimer's disease other than donepezil or the rivastigmine transdermal system, including oral rivastigmine (Exelon) or galantamine (Razadyne)

In this study, participants will be randomly assigned to one of three groups. Two groups will test the drug T-817MA, a neuroprotective agent that acts on amyloid-induced neurotoxicity and memory deficits. The third group will receive a placebo (inactive drug). The efficacy of two different doses of the drug, 224 mg and 448 mg, taken once daily, will be compared. Participants will take tests to determine the drug's effects on memory, other aspects of cognition, and daily functioning. Physical exams, blood tests, and brain scans (MRI) will also be done. Total participation time is about 14 months

For more information about the NOBLE study, visit www.noblestudy.org.

Name City State Zip Status Primary Contact
Banner Alzheimer's Institute
Phoenix Arizona

Banner Sun Health Research Institute
Sun City Arizona

University of Arizona Health Sciences Center
Tucson Arizona

Neurology Center of North Orange County
Fullerton California

UCSD Comprehensive Alzheimer's Program
La Jolla California

UC Irvine Medical Center
Orange California

Geriatric and Adult Psychiatry, LCC
Hamden Connecticut

Yale University, Alzheimer's Disease Research Unit
New Haven Connecticut

Research Center for Clinical Studies, Inc.
Norwalk Connecticut

Georgetown University Clinical Research Unit
Washington District of Columbia

Infinity Clinical Research, LLC
Hollywood Florida

University of Miami Miller-School of Medicine
Miami Florida

Scientific Clinical Research, Inc
North Miami Florida

Renstar Medical Research
Ocala Florida

Meridien Research
Tampa Florida

Neuro Trials Research, Inc
Atlanta Georgia

Rush University Medical Center
Chicago Illinois

SIU School of Medicine
Springfield Illinois

Indiana Medical Research
Elkhart Indiana

Indiana University Health Partners, Adult Neurology Clinic
Indianapolis Indiana

University of Iowa Hospitals and Clinics
Iowa City Iowa

University of Kansas/Clinical and Translational Science Unit
Fairway Kansas

University of Kentucky Sanders-Brown Center on Aging Clinic
Lexington Kentucky

Pennington Biomedical Research Center
Baton Rouge Louisiana

Acadia Hospital
Bangor Maine

Boston University Alzheimer's Disease Center
Boston Massachusetts

University of Michigan Health System/ Michigan Clinical Research Unit
Ann Arbor Michigan

Michigan State University
East Lansing Michigan

Bronson Neurobehvioral Health
Paw Paw Michigan

University of Nebraska Medical Center(Geri Psych)
Omaha Nebraska

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada

Global Medical Institutes, LLC;Princeton Medical Institute
Princeton New Jersey

Dent Neurologic Institute
Amherst New York

Alzheimer's Disease Research Center of Mount Sinai
New York New York

Columbia University Medical Center Sergievsky Center Taub Institute
New York New York

The Nathan S. Kline Instituite for Psychiatric Research
Orangeburg New York

University of Rochester Medical Center
Rochester New York

SUNY Upstate Medical University
Syracuse New York

Wake Forest University (WFU) School of Medicine
Winston-Salem North Carolina

Case Western Reserve University/ University Hospitals Case Medical Center
Beachwood Ohio

Tulsa Clinical Research, LLC
Tulsa Oklahoma

Hospital at the University of Pennsylvania, Penn Memory Center
Philadelphia Pennsylvania

University of Pittsburgh, Alzheimer Disease Research Center
Pittsburgh Pennsylvania

Abington Neurological Associates, LTD.
Willow Grove Pennsylvania

Roper St. Francis Healthcare
Charleston South Carolina

Vanderbilt University Medical Center -VUIIS
Nashville Tennessee

University of North Texas Health Science Center
Fort Worth Texas

Houston Methodist Hospital
Houston Texas

University of Wisconsin Hospital and Clinics
Madison Wisconsin

Cary J. Kohlenberg MD., SC dba IPC Research
Waukesha Wisconsin

Toyama Chemical Co., Ltd.

  • Alzheimer's Disease Cooperative Study (ADCS)

Name Phone Email
Genny Matthews 858-246-1318 gfmatthews@mail.ucsd.edu

NCT02079909

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