Here's that S-18986 MCI trial, from the Clinical trials.gov site. It's surprisingly large (400 patients, though perhaps they're expecting a lot of dropouts), and has both high and low dose cohorts. I thought the 12 month dosing regimen was very surprising, since we had previously heard rumblings that S-18986 may have had some side effect problems. MCI is a tough indication, since as we saw with the CX-516 study, MCI patients tend to be sensitive to side effects (perhaps because unlike AD patients, their cognitive symptoms aren't yet very severe, making them less motivated to stay on the treatment). If S-18986 causes nausea or headache problems, it's going to be tough to keep these folks on drug for a whole year -
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 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: 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: September 12, 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 2006-11-17
