Evaluation of the effect of 6 months treatment with V0191 on symptoms changes in patients with Mild Cognitive Impairment. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.

PIERRE FABRE MEDICAMENT - IDPF0 sites200 target enrollmentJanuary 17, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 17, 2008

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

PIERRE FABRE MEDICAMENT - IDPF

•\- men or women aged 55 to 90 years,
•\- progressive cognitive decline fulfilling the criteria for MCI :
•\* memory complaint, corroborated by immediate family,
•\* amnesic syndrome of hippocampal type (isolated or associated with other cognitive disorders) with the following results obtained for the Grober and Buschke test: free recall \< or \= 20 ; total recall \< or \= 40,
•\* normal or sufficiently preserved daily activities in order to exclude the diagnosis of dementia,
•\* abscence of dementia (DSM\-IV),
•\- MMSE score between 24 and 30,
•\- global score of 0\.5 on the CDR scale with a Memory domain score of 0\.5 or 1, no scores \>1,
•\- mastering the French language,
•\- having given his/her written consent to take part in the study,

•CRITERIA RELATED TO THE STUDIED DISEASE:
•\- patient in whom a diagnosis of dementia is suspected or has already been made,
•\- presence of serious disease which may soon become life\-threatening,
•\- patient cerebrovascular disease with a Hachinski scale score \> 4,
•\- patient with a progressive and/or poorly balanced psychiatric disorder according to DSM\-IV,
•\- patient with the following neurological disorders : epilepsy, dementia irrespective of cause, Parkinson's disease, presence of images suggesting vascular disease,
•\- patient with known vitamin B12 or folate deficiency (unless having received supplements at stable dose for at least 6 months prior to selection) or known syphilis,
•\- patient with sleep apnoea syndrome.
•CRITERIA RELATED TO PREVIOUS OR CONCOMITANT MEDICATION:
•\- patient with a known allergy to the investigational product or to one of the ingredients,