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European Study of 3APS in Mild to Moderate Alzheimer's Disease Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Bellus Health Inc.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Bellus Health Inc
Information provided by:
Bellus Health Inc
ClinicalTrials.gov Identifier:
NCT00217763
First received: September 14, 2005
Last updated: December 7, 2007
Last verified: December 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: 3APS | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind |
| Official Title: | A Phase III Study of the Efficacy and Safety of 3APS as Add-on Therapy in Mild to Moderate Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Bellus Health Inc:
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217763
Show 69 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217763
Show 69 Study Locations
Sponsors and Collaborators
Bellus Health Inc
Investigators
| Principal Investigator: | Pr. Bruno Vellas | University Hospital Center, Toulouse |
More Information
| ClinicalTrials.gov Identifier: | NCT00217763 History of Changes |
| Other Study ID Numbers: |
CL-758010 |
| Study First Received: | September 14, 2005 |
| Last Updated: | December 7, 2007 |
Keywords provided by Bellus Health Inc:
|
Dementia Alzheimer's disease |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders |
Mental Disorders Tramiprosate Anticonvulsants GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 17, 2017