Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatment 3aps
Phase phase 3
Sponsor Bellus Health Inc
Start date September 2005
End date December 2007
Trial size 930 participants
Trial identifier NCT00217763, CL-758010

Summary

The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind

Eligibility Criteria

Male or female participants at least 50 years old.

RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES. INCLUSION CRITERIA: Participants must meet the following inclusion criteria to be eligible. - Male or Female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal). - Diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria). - Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit. - Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver. - Potential participant must be treated with an acetylcholinesterase inhibitor (donepezil, galantamine or rivastigmine) and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period. - Participants must not have taken memantine for at least 4 months prior to the commencement of screening. The use of memantine is prohibited during the course of the study. - Fluency (oral and written) in the language in which the standardized tests will be administered. - Signed informed consent from potential participant or legal representative and caregiver. EXCLUSION CRITERIA: Patients will not be eligible to participate in the study if they meet any of the following criteria: - Potential participant with any other cause of dementia. - Life expectancy less than 2 years. - Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease. - Previous use of anti-amyloid or vaccine treatment for Alzheimer's disease. - Use of an investigational drug within 30 days prior to the screening visit or during the entire study. - Previous exposure to 3APS. - Inability to swallow pills.

Additional Information

Official title A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease
Principal investigator Pr. Bruno Vellas
Description - Duration of treatment: 18 months - 3 treatment arms: Placebo and 2 different doses of active drug.
Trial information was received from ClinicalTrials.gov and was last updated in December 2007.
Information provided to ClinicalTrials.gov by Bellus Health Inc.