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

Bellus Health

Status and phase

Unknown

Phase 3

Conditions

Alzheimer's Disease

Treatments

Drug: Tramiprosate (3APS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00314912

CL-758017

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.