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

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

The purpose of this study is to demonstrate a long term efficacy of S18986 versus placebo on episodic memory performance in patients with MCI

Study Overview

• Status: Terminated
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Drug: S18986

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • Hôpital la Grave-Casselardit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Episodic memory

Secondary Outcome Measures

Outcome Measure
Other cognitive domains, activities of daily living, global impression of change, MRI, safety.

Collaborators and Investigators

• Sponsor: Institut de Recherches Internationales Servier
• Investigators: Study Chair: Bruno Vellas, MD, Hôpital la Grave-Casselardit, Toulouse

Publications and helpful links

Helpful Links

• Results summary

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): March 29, 2006
• Study Completion (Actual): March 29, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimated): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: CL2-18986-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR