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

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

Sponsors

Lead sponsor: FUJIFILM Toyama Chemical Co., Ltd.

Collaborator: Alzheimer's Disease Cooperative Study (ADCS)

Source 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).

Overall Status Completed
Start Date March 2014
Completion Date May 5, 2017
Primary Completion Date May 5, 2017
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
ADAS-cog Change From Baseline to Week 52 Baseline and 52 weeks
CGIC 52 weeks
Secondary Outcome
Measure Time Frame
ADCS-ADL Change From Baseline to Week 52 Baseline and 52 weeks
Enrollment 482
Condition
Intervention

Intervention type: Drug

Intervention name: T-817MA-H

Description: 224 mg or 448 mg T-817 MA once daily

Arm group label: T-817MA-H

Intervention type: Drug

Intervention name: T-817MA-L

Description: 224 mg T-817 MA once daily

Arm group label: T-817MA-L

Intervention type: Drug

Intervention name: Placebo

Description: Placebo

Arm group label: Placebo

Eligibility

Criteria:

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®)

Gender: All

Minimum age: 55 Years

Maximum age: 85 Years

Healthy volunteers: No

Location
facility
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, 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
Location Countries

United States

Verification Date

February 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: T-817MA-H

Arm group type: Experimental

Description: 224 mg T-817MA once daily for first 4 weeks and 448 mg T-817MA once daily for the following weeks.

Arm group label: T-817MA-L

Arm group type: Experimental

Description: 224 mg T-817MA once daily

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Placebo once daily

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov