Efficacy and Safety of S18986 in the Treatment of Mild Cognitive Impairment Patients

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Servier
ClinicalTrials.gov Identifier:
NCT00202540
First received: September 12, 2005
Last updated: November 15, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to demonstrate a long term efficacy of S18986 versus placebo on episodic memory performance in patients with MCI


Condition Intervention Phase
Mild Cognitive Impairment
Drug: S18986
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Efficacy of 15 mg and 50 mg of S18986 on Cognitive Symptoms in Mild Cognitive Impairment Patients Treated Over a 12-month Oral Administration Period

Resource links provided by NLM:


Further study details as provided by Servier:

Primary Outcome Measures:
  • Episodic memory

Secondary Outcome Measures:
  • Other cognitive domains, activities of daily living, global impression of change, MRI, safety.

Estimated Enrollment: 450
Study Start Date: June 2005
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Memory complaint
  • Acetylcholinesterase inhibitors stopped at least 3 months before selection

Exclusion Criteria:

  • Dementia
  • Parkinson's disease
  • Vascular disorder
  • Depression
  • Epilepsy
  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: NCT00202540

Locations
France
Hôpital la Grave-Casselardit
Toulouse, France, 31000
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Investigators
Study Chair: Bruno Vellas, MD Hôpital la Grave-Casselardit, Toulouse
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00202540     History of Changes
Other Study ID Numbers: CL2-18986-009
Study First Received: September 12, 2005
Last Updated: November 15, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 22, 2014