Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease

Status unconfirmed · Phase 3

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00314912

Run by

Bellus Health Inc. - a GSK company

People needed

650

Starts

2006-05-01

Last updated by the study team

2007-07-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco Clinical Research Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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