Efficacy and Safety of S18986 in the Treatment of Mild Cognitive Impairment Patients - Full Text View

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
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:

Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on October 22, 2008