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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

April 18, 2008
October 9, 2013
April 2008
May 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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: T-817MA
    224 mg T-817 MA once daily
  • Drug: Placebo
    Placebo once daily
  • Experimental: 1
    T-817MA once daily
    Intervention: Drug: T-817MA
  • Placebo Comparator: 2
    Placebo once daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
June 2011
May 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 information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00663936
AA4437420
Yes
Toyama Chemical Co., Ltd.
Toyama Chemical Co., Ltd.
Not Provided
Not Provided
Toyama Chemical Co., Ltd.
December 2012

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