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Efficacy and Safety of S18986 in the Treatment of Mild Cognitive Impairment Patients
This study is currently recruiting participants.
Verified by Servier, September 2005
Sponsored by: Institut De Recherche International Servier
Information provided by: Servier
ClinicalTrials.gov Identifier: NCT00202540
  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 II

MedlinePlus related topics: Memory
Drug Information available for: (S)-2,3-dihydro-(3,4)cyclopentano-1,2,4-benzothiadiazine-1,1-dioxide
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

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
  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

Contacts
Contact: Bruno Vellas, MD + 33 5 61 77 76 49

Locations
France
Hôpital la Grave-Casselardit Recruiting
Toulouse, France, 31000
Contact: Bruno Vellas, MD     + 33 5 61 77 76 49        
Sponsors and Collaborators
Institut De Recherche International Servier
Investigators
Study Chair: Bruno Vellas, MD Hôpital la Grave-Casselardit, Toulouse
  More Information

Study ID Numbers: CL2-18986-009
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00202540  
Health Authority: France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
 Neurobehavioral Manifestations
Cognition Disorders
Delirium

ClinicalTrials.gov processed this record on January 15, 2009



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