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Clinical Trials/NCT00314912
NCT00314912
Unknown
Phase 3

An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease

Bellus Health Inc. - a GSK company1 site in 1 country650 target enrollmentMay 2006
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ConditionsAlzheimer's Disease
DrugsTramiprosate (3APS)

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
Bellus Health Inc. - a GSK company
Enrollment
650
Locations
1
Primary Endpoint
To evaluate the long-term safety of Tramiprosate (3APS).
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
May 2006
End Date
TBD
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Bellus Health Inc. - a GSK company

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.

Outcomes

Primary Outcomes

To evaluate the long-term safety of Tramiprosate (3APS).

Secondary Outcomes

  • To provide additional long-term data on the efficacy of Tramiprosate (3APS).

Study Sites (1)

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