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

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:

Male or female (post-menopausal or surgically sterile)
Patients with Mild to moderate Alzheimer's disease who are receiving Donepezil.
Age 50 to 90 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 etc (According to the protocol)

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 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
Study 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 January 16, 2009