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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.
Study NCT00663936   Information provided by Toyama Chemical Co., Ltd.
First Received: April 18, 2008   Last Updated: September 16, 2009   History of Changes

April 18, 2008
September 16, 2009
April 2008
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00663936 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Alzheimer's Disease
  • Drug: T-817MA
  • Drug: Placebo
  • Experimental: T-817MA once daily
  • Placebo Comparator: Placebo once daily
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
326
September 2011
March 2011   (final data collection date for primary outcome measure)

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).
Both
50 Years to 90 Years
No
Contact: Jeremy Johnston 1-800-554-0502 ext 294 JJohnston@incresearch.com
United States,   Canada
 
NCT00663936
Dr. Katsumi Shimizu, Development Management Department, Toyama Chemical Co., Ltd.
AA4437420
Toyama Chemical Co., Ltd.
 
 
Toyama Chemical Co., Ltd.
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP