Efficacy and Safety of S18986 in the Treatment of Mild Cognitive Impairment Patients
This study is currently recruiting patients.
Verified by Servier September 2005
Sponsored by: Institut de Recherches Internationales 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: Mental Health; Neurologic Diseases
Genetics Home Reference related topics: Neurologic Diseases
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 Outcomes: Episodic memory
Secondary Outcomes: Other cognitive domains, activities of daily living, global impression of change, MRI, safety.
Expected Total Enrollment: 450
Study start: June 2005
Eligibility
Ages Eligible for Study: 55 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Memory complaint
Acetylcholinesterase inhibitors stopped at least 3 months before selection
Exclusion Criteria:
Dementia
Parkinson's disease
Vascular disorder
Depression
Epilepsy
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00202540
Bruno Vellas, MD + 33 5 61 77 76 49
France
Hôpital la Grave-Casselardit, Toulouse, 31000, France; Recruiting
Bruno Vellas, MD + 33 5 61 77 76 49
Study chairs or principal investigators
Bruno Vellas, MD, Study Chair, Hôpital la Grave-Casselardit, Toulouse
More Information
Study ID Numbers: CL2-18986-009
Last Updated: December 8, 2005
Record first received: September 12, 2005
ClinicalTrials.gov Identifier: NCT00202540
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2006-05-04
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