EUCTR2007-001975-12-FR
Active, not recruiting
Phase 1
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 enrollmentMay 18, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- PIERRE FABRE MEDICAMENT - IDPF
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- men or women aged 55 to 90 years,
- •\- progressive cognitive decline fulfilling the criteria of 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,
- •\- 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,
- •\- if stipulated by national regulatory requirements, patient covered by a social security or health insurance system.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •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 deficinecy (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 known allergy to investigational product or to one of the ingredients,
Outcomes
Primary Outcomes
Not specified
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