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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202540
Recruitment Status : Terminated
First Posted : September 20, 2005
Last Update Posted : March 20, 2018
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: S18986 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2005
Primary Completion Date : March 29, 2006
Study Completion Date : March 29, 2006

Primary Outcome Measures :
  1. Episodic memory

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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00202540

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

Additional Information: Identifier: NCT00202540     History of Changes
Other Study ID Numbers: CL2-18986-009
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders