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
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014