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
Sponsor:
Information provided by:
Bellus Health Inc
ClinicalTrials.gov Identifier:
NCT00217763
First received: September 14, 2005
Last updated: December 7, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
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:


Further study details as provided by Bellus Health Inc:

Estimated Enrollment: 930
Study Start Date: September 2005
Estimated Study Completion Date: December 2007
Detailed Description:
  • Duration of treatment: 18 months
  • 3 treatment arms:

Placebo and 2 different doses of active drug.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00217763     History of Changes
Other Study ID Numbers: CL-758010
Study First Received: September 14, 2005
Last Updated: December 7, 2007
Health Authority: 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: Federal Agency for Medicines and Health Products, FAMHP
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
Switzerland: Swissmedic

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Homotaurine
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014