Status:
UNKNOWN
Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Bellus Health Inc. - a GSK company
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00314912
Start Date
May 1 2006
Last Update
July 16 2007
Active Locations (1)
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1
San Francisco Clinical Research Center
San Francisco, California, United States