Alzheimer's Disease
Conditions
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
Interventions
DRUGTramiprosate (3APS)
Sponsors
Bellus Health Inc. - a GSK company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the long-term safety of Tramiprosate (3APS). | — |
Secondary
| Measure | Time frame |
|---|---|
| To provide additional long-term data on the efficacy of Tramiprosate (3APS). | — |
Countries
United States
Outcome results
None listed