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

This study is currently recruiting participants.
Verified by Toyama Chemical Co., Ltd., September 2008

Sponsored by: Toyama Chemical Co., Ltd.
Information provided by: Toyama Chemical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00663936
  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 II

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease    Dementia   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:   326
Study Start Date:   April 2008
Estimated Study Completion Date:   September 2010
Estimated Primary Completion Date:   March 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
T-817MA once daily
Drug: T-817MA
224 mg T-817 MA once daily
2: Placebo Comparator
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

Contacts
Contact: Jeremy Johnston     1-800-554-0502 ext 294     Jeremy.Johnston@mdsinc.com    

Locations
United States, Arizona
Northwest NeuroSpecialists     Recruiting
      Tucson, Arizona, United States, 85741
      Contact: Joan Laguna, CCRC     520-742-1833     jlaguna@neuroresearch.com    
      Principal Investigator: Jeanette Wendt, MD            
United States, California
San Francisco Clinical Research Center     Recruiting
      San Francisco, California, United States, 94109
      Contact: Michael Miller     415-673-4600     sfhaclin@aol.com    
      Principal Investigator: Jerome Goldstein, MD            
Southwest Institute for Clinical Research, Inc.     Recruiting
      Rancho Mirage, California, United States, 92270
      Contact: Linda Roger, RN     760-773-9117     LRogerRN@aol.com    
      Principal Investigator: Richard Hubbard, MD            
Margolin Brain Institute     Recruiting
      Fresno, California, United States, 93720
      Contact: Jann J Margolin, FNP, MBA     559-299-1515     dimmd@sbcglobal.net    
      Principal Investigator: David I Margolin, MD, PhD            
Pacific Research Network, Inc.     Recruiting
      San Diego, California, United States, 92103
      Contact: Nicole Robles     619-294-4302     nrobles@prnsd.com    
      Principal Investigator: Stephen G Thein, PhD            
United States, Colorado
Radiant Research     Recruiting
      Denver, Colorado, United States, 80212
      Contact: Burlleen Hewitt     303-480-7122     burlleen.hewitt@radiantresearch.com    
      Principal Investigator: Leslie Moldauer, MD            
United States, Connecticut
Geriatric and Adult Psychiatry, LCC     Recruiting
      Hamden, Connecticut, United States, 06518
      Contact: Andrea DeClement     203-288-0414     adeclement@geriatrics-psych.com    
      Principal Investigator: Alan Siegal, MD            
United States, Florida
Axiom Clinical Research of Florida     Recruiting
      Tampa, Florida, United States, 33609
      Contact: Kathleen Carlson     813-353-9613     kcarlson.axiom@verizon.net    
      Principal Investigator: Susan J Steen, MD            
Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute     Recruiting
      Tampa, Florida, United States, 33613
      Contact: Amy T Giordano, MPH     813-866-1611     agiordano@byrdinstitute.org    
      Principal Investigator: Ashok Raj, MD            
Premiere Research Institute     Recruiting
      West Palm Beach, Florida, United States, 33407
      Contact: Teresa Villena     561-845-0500 ext 142     tvillena@aol.com    
      Principal Investigator: Carl Sadowsky, MD            
Anchor Research Center     Recruiting
      Naples, Florida, United States, 34102
      Contact: Briana Foerman     239-643-8805     bfoerman@ahresearchcenter.com    
      Principal Investigator: Ashley Tunkle, MD            
United States, Georgia
Columbia Research & Wellness Institute     Recruiting
      Columbus, Georgia, United States, 31907
      Contact: Theresa Harris     706-653-0419     theresaharris@healingshoppe.com    
      Principal Investigator: Reinaldo Verson, MD            
United States, Indiana
Agewell     Recruiting
      Indianapolis, Indiana, United States, 46260
      Contact: Rebecca Hancock, RN     317-846-9792     bhancock@agewell.biz    
      Principal Investigator: Stephen Rappaport, MD            
United States, Kentucky
Four Rivers Clinical Research, Inc.     Recruiting
      Paducah, Kentucky, United States, 42003
      Contact: Debra Adamson     270-441-4606     dadamson@fourriversresearch.com    
      Principal Investigator: David Stricklin, MD            
United States, Nevada
University of NV, School of Med., Dept. Psychiatry     Recruiting
      Las Vegas, Nevada, United States, 89102
      Contact: Michelle Sholar     702-671-5058     msholar@medicine.nevada.edu    
      Principal Investigator: Charles B Bernick, MD            
United States, New York
Alzheimer's Disease Center, U. of Rochester Medical Center     Recruiting
      Rochester, New York, United States, 14620
      Contact: Bonnie Goldstein     585-760-6561     BonnieS_Goldstein@URMC.rochester.edu    
      Principal Investigator: Anton Porsteinsson, MD            
Richmond Behavioral Associates     Recruiting
      Staten Island, New York, United States, 10312
      Contact: Tatiana Kundla     718-317-5522     patakyova@rbany.com    
      Principal Investigator: Mark DiBuono, MD            
Brooklyn Medical Institute     Recruiting
      Brooklyn, New York, United States, 11223
      Contact: Marina Mazur     718-339-7711     mmazur@gminstitutes.com    
      Principal Investigator: Zinoviy Benzar, MD Ph.D.            
Neurological Association of Albany, P.C.     Recruiting
      Albany, New York, United States, 12208
      Contact: Toni Hansen     518-426-0575     researchnaa@aol.com    
      Principal Investigator: Richard F Holub, MD            
United States, Texas
Innovative Clinical Trials     Recruiting
      San Antonio, Texas, United States, 78229
      Contact: Elizabeth Hendrix     210-377-2873     Elizabeth.Hendrix@innovativeclincialtrials.com    
      Principal Investigator: James E Garrison, MD            
Senior Adults Specialty Research     Recruiting
      Austin, Texas, United States, 78757
      Contact: Luisa Sansalone     512-407-8628     lsansalone@senioradults.net    
      Principal Investigator: Jaron L Winston, MD            
United States, Wisconsin
IPC Research     Recruiting
      Waukesha, Wisconsin, United States, 53188
      Contact: Anne Dobratz     262-513-0700 ext 230     annedobratz@sbcglobal.net    
      Principal Investigator: Cary Kohlenberg, MD            

Sponsors and Collaborators
Toyama Chemical Co., Ltd.
  More Information


Responsible Party:   Toyama Chemical Co., Ltd. ( Dr. Katsumi Shimizu, Development Management Department )
Study ID Numbers:   AA4437420
First Received:   April 18, 2008
Last Updated:   September 19, 2008
ClinicalTrials.gov Identifier:   NCT00663936
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 06, 2008




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