Have you or a loved one been diagnosed with Alzheimer's Disease?
Find participating site locations for the study.

Study Overview

Protocol 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.”

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. Population pharmacokinetics of T-817MA will also be analyzed in the patient population.

Study Design: This is a Phase 2a, randomized, placebo-controlled, double-blind, multi-center study for 52 weeks in patients with Alzheimer's disease.

Patients will be screened in order to determine eligibility for the study. Patients who meet the inclusion criteria will be randomized into either the placebo or 224 mg T-817MA dose groups. A final follow-up visit will be conducted 4 weeks after completion of study medication.

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. Patients that have dementia not of the Alzheimer's type (according to the protocol).
  3. Patients who are taking any drug other than donepezil for Alzheimer's disease, including rivastigmine (Exelon®), galantamine (Razadyne®), or tacrine (Cognex®). Patients who are taking memantine (Namenda™) within eight (8) weeks of the Baseline Visit (Visit 2).

Locations:

There are currently 24 participating study sites located in the Unites States.
View the site locations.

This information can also be found by visiting the study listing on ClinicalTrials.gov.