This trial is active, not recruiting.

Condition alzheimer's disease
Treatment tramiprosate (3aps)
Phase phase 3
Sponsor Bellus Health Inc
Start date May 2006
Trial size 650 participants
Trial identifier NCT00314912, CL-758017


The purpose of this Phase III open-label extension study is to evaluate the long-term safety of Tramiprosate (3APS) in patients with mild to moderate Alzheimer’s disease.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

To evaluate the long-term safety of Tramiprosate (3APS).
time frame:

Secondary Outcomes

To provide additional long-term data on the efficacy of Tramiprosate (3APS).
time frame:

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - The patient must have successfully completed the full 78-week duration of the double-blind CL-758007 study. - 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). - 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. - The patient must be presenting a reasonably good nutritional status. - Signed inform consent from the patient or legal representative. Exclusion Criteria: Patients will not be eligible to participate in the study if they meet any of the following criteria: - The patient participates in another drug trial during the study. - The patient with a clinically significant and/or uncontrolled condition or other significant medical disease. - The patient is unable to swallow medication tablets.

Additional Information

Official title An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease
Description Duration of treatment: 12 months. Patients who complete the Phase III clinical trial will be offered the opportunity to receive Tramiprosate (3APS) in an open-label extension study
Trial information was received from ClinicalTrials.gov and was last updated in July 2007.
Information provided to ClinicalTrials.gov by Bellus Health Inc.