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.
- Conditions
- Mild Cognitive ImpairmentMedDRA version: 9.1Level: LLTClassification code 10009846Term: Cognitive impairment
- Registration Number
- EUCTR2007-001975-12-FR
- Lead Sponsor
- PIERRE FABRE MEDICAMENT - IDPF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
- 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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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,
- patient with unstable hypertension (SBP > 160 mmHg and/or DBP > 95 mmHg) evaluated by the investigator,
- patient previously treated with centrally-acting anticholinesterase or memantine irrespective of treatment duration and date prescribed,
- patient currently treated with a product indicated for the symptomatic treatment of chronic neurosensory or cognitive pathological impairment in elderly subjects (Gingko biloba, almitrine, piracetam,..),
- patient having received, during the 2 months prior to inclusion, a prodcut indicated for the symptomatic treatment of chronic neurosensory or cognitive pathological impairment in elderly subjects.
CRITERIA RELATED TO THE PATIENTS
- patients with visual or hearing disorders incompatible with the conduct and/or interpretation of neuropsychological tests,
- patients living in a nursing home,
- patient without a reliable caregiver,
- patient incapable of taking the investigational product as stipulated throughout the duration of the study,
- patient displaying criteria for psychoactive substance abuse or dependency,
- patient suffering from immunosuppression or insulin-dependent diabetes mellitus or diabetes mellitus not stabilised by dietary measures and/or oral hypoglycaemics, obstructive pulmonary disease, unstable asthma, recent oncological and/or haematological disorders (< or = to 2 years),
- history or ongoing gastrointestinal, hepatic or renal disease, or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicinal products,
- history of a cardiovascular event in the past 6 months,
- patient with severe chronic or acute disease considered by the investigator as incompatible with study implementation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method