European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Bellus Health Inc.
Recruitment status was Active, not recruiting
Information provided by:
Bellus Health Inc
First received: September 14, 2005
Last updated: December 7, 2007
Last verified: December 2007
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) in patients with mild to moderate Alzheimer's disease.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
||A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
- Duration of treatment: 18 months
- 3 treatment arms:
Placebo and 2 different doses of active drug.
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
RECRUITMENT OF PARTICIPANTS IS PERFORMED ONLY BY STUDY SITES.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217763
Bellus Health Inc
||Pr. Bruno Vellas
||University Hospital Center, Toulouse
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 14, 2005
||December 7, 2007
||European Union: European Medicines Agency
United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Directorate general for the protection of Public health: Medicines
Spain: Spanish Agency of Medicines
Italy: Ministry of Health
Sweden: Medical Products Agency
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Bellus Health Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Agents