Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease
This trial is active, not recruiting.
|Sponsor||Bellus Health Inc|
|Start date||May 2006|
|Trial size||650 participants|
|Trial identifier||NCT00314912, CL-758017|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To evaluate the long-term safety of Tramiprosate (3APS).
To provide additional long-term data on the efficacy of Tramiprosate (3APS).
Male or female participants at least 50 years old.
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.
|Official title||An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease|
|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|
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