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Completed

NCT Number: NCT00663936

Efficacy and Safety of T-817MA 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Joseph's Hospital, Saint John, New Brunswick, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

T-817MA

Drug

224 mg T-817 MA once daily

Placebo

Drug

Placebo once daily

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

FUJIFILM Toyama Chemical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 22, 2008
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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