Title

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
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    t-817ma ...
  • Study Participants

    373
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.
Study Started
Apr 30
2008
Primary Completion
May 31
2011
Study Completion
Jun 30
2011
Last Update
Nov 05
2013
Estimate

Drug T-817MA

224 mg T-817 MA once daily

Drug Placebo

Placebo once daily

1 Experimental

T-817MA once daily

2 Placebo Comparator

Placebo once daily

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).
No Results Posted