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
1 other identifier
interventional
38
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2005
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2006
CompletedJuly 25, 2024
July 1, 2024
10 months
September 12, 2005
July 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Episodic memory
Secondary Outcomes (1)
Other cognitive domains, activities of daily living, global impression of change, MRI, safety.
Interventions
Eligibility Criteria
You may qualify if:
- Memory complaint
- Acetylcholinesterase inhibitors stopped at least 3 months before selection
You may not qualify if:
- Dementia
- Parkinson's disease
- Vascular disorder
- Depression
- Epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital la Grave-Casselardit
Toulouse, 31000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bruno Vellas, MD
Hôpital la Grave-Casselardit, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
June 1, 2005
Primary Completion
March 29, 2006
Study Completion
March 29, 2006
Last Updated
July 25, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.