Status:
UNKNOWN
European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients
Lead Sponsor:
Bellus Health Inc. - a GSK company
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this Phase 3 study is to evaluate the efficacy and safety of 3APS as an add-on therapy to most standard medication for Alzheimer's disease compared to placebo (inactive substance pill) ...
Detailed Description
* Duration of treatment: 18 months * 3 treatment arms: Placebo and 2 different doses of active drug.
Eligibility Criteria
Inclusion
- RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES.
- INCLUSION CRITERIA:
- Participants must meet the following inclusion criteria to be eligible.
- 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).
- Diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria).
- Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit.
- 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.
- Potential participant must be treated with an acetylcholinesterase inhibitor (donepezil, galantamine or rivastigmine) and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period.
- Participants must not have taken memantine for at least 4 months prior to the commencement of screening. The use of memantine is prohibited during the course of the study.
- Fluency (oral and written) in the language in which the standardized tests will be administered.
- Signed informed consent from potential participant or legal representative and caregiver.
- EXCLUSION CRITERIA:
- Patients will not be eligible to participate in the study if they meet any of the following criteria:
- Potential participant with any other cause of dementia.
- Life expectancy less than 2 years.
- Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease.
- Previous use of anti-amyloid or vaccine treatment for Alzheimer's disease.
- Use of an investigational drug within 30 days prior to the screening visit or during the entire study.
- Previous exposure to 3APS.
- Inability to swallow pills.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
930 Patients enrolled
Trial Details
Trial ID
NCT00217763
Start Date
September 1 2005
End Date
December 1 2007
Last Update
December 10 2007
Active Locations (69)
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1
Middelheim Ziekenhuis Lindendreef
Antwerp, Belgium
2
University Hospital Antwerp - Neurology - Prof. Dr. Patrick Cras, MD, PhD
Edegem, Belgium, 2650
3
Memory Clinic University Hospital Gasthuisberg, Neurology Department
Leuven, Belgium, 3000
4
Memory Centre, Polycliniques Brull, CHU de Liège
Liège, Belgium