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

A Phase 2a Multi-center, Randomized, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of T-817MAa in Patients With Mild to Moderate Alzheimer's Disease

The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.

The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Placebo; Drug: T-817MA

• Study Type: Interventional
• Enrollment (Actual): 373
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • St. John, New Brunswick, Canada, E2L 3L6
      • St. Joseph's Hospital
  • Ontario
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
    • Tucson, Arizona, United States, 85741
      • Northwest NeuroSpecialists
  • California
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network, Inc.
    • Rancho Mirage, California, United States, 92270
      • Southwest Institute for Clinical Research, Inc.
    • San Diego, California, United States, 92103
      • Pacific Research Network, Inc.
    • San Francisco, California, United States, 94109
      • San Francisco Clinical Research Center
  • Colorado
    • Denver, Colorado, United States, 80239
      • Radiant Research
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Geriatric and Adult Psychiatry, LCC
    • Norwalk, Connecticut, United States, 06851
      • Research Center for Clinical Studies, Inc.
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • NeuroPsychiatric Center of the Palm Beaches
    • Miami Springs, Florida, United States, 33166
      • Galiz Research
    • Naples, Florida, United States, 34102
      • Anchor Research Center
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
    • Tampa, Florida, United States, 33613
      • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Columbus, Georgia, United States, 31907
      • Columbus Research & Wellness Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Agewell
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic - Lou Ruvo Center for Brain Health
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
    • Toms River, New Jersey, United States, 08755
      • Memory Enhancement Center of America
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials
    • Brooklyn, New York, United States, 11214
      • Brooklyn Medical Institute
    • Rochester, New York, United States, 14620
      • Alzheimer's Disease Center, U. of Rochester Medical Center
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • The Alzheimer's Memory Center
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates
    • Winston Salem, North Carolina, United States, 27103
      • Clinical Trials of America, Inc.
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trials Center
    • Philadelphia, Pennsylvania, United States, 19139
      • CRI Worldwide, LLC
  • Texas
    • San Antonio, Texas, United States, 78229
      • Innovative Clinical Trials
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • IPC Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female (post-menopausal or surgically sterile)
2. Patients with Mild to moderate Alzheimer's disease who are receiving Donepezil.
3. Age 50 to 90 inclusive
4. Patients must be living in the community
5. Patients must have an eligible informant or study partner (caregiver)
6. Patients and eligible informant or study partner (caregiver) must be able to read and understand English.
7. Informed consent obtained from both the patient and the caregiver etc (According to the protocol)

Exclusion Criteria:

1. Patients with clinically significant cardiac, hepatic or renal impairment
2. Patient have a dementia not of the Alzheimer's type etc (According to the protocol)
3. Patients who are taking any drug other than donepezil for Alzheimer's disease, including rivastigmine (Exelon®), galantamine (Razadyne®), memantine (Namenda™) or tacrine (Cognex®) taken within twelve (12) weeks of the Baseline Visit (Visit 2).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; T-817MA once daily	Drug: T-817MA; 224 mg T-817 MA once daily
Placebo Comparator: 2; Placebo once daily	Drug: Placebo; Placebo once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary objectives are to evaluate the safety of T-817MA and the activities of daily living (ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.	52 weeks

Collaborators and Investigators

• Sponsor: FUJIFILM Toyama Chemical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: October 9, 2013
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Alzheimer's
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: AA4437420