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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Toyama Chemical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00663936
First received: April 18, 2008
Last updated: October 9, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: T-817MA
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Toyama Chemical Co., Ltd.:

Primary Outcome Measures:
  • 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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: April 2008
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663936

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

No publications provided

Responsible Party: Toyama Chemical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00663936     History of Changes
Other Study ID Numbers: AA4437420
Study First Received: April 18, 2008
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Toyama Chemical Co., Ltd.:
Alzheimer's Disease
Alzheimer's

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014