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

NCT00314912

UnknownPhase 3

Sponsor: Bellus Health Inc. - a GSK company

Conditions: Alzheimer's Disease

Interventions: Tramiprosate (3APS)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

San Francisco, California, United States