Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease
Phase 3
- Conditions
- Alzheimer's Disease
- Registration Number
- NCT00314912
- Lead Sponsor
- Bellus Health Inc. - a GSK company
- Brief Summary
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.
- Detailed 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 650
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the long-term safety of Tramiprosate (3APS).
- Secondary Outcome Measures
Name Time Method To provide additional long-term data on the efficacy of Tramiprosate (3APS).
Trial Locations
- Locations (1)
San Francisco Clinical Research Center
🇺🇸San Francisco, California, United States