Mild Cognitive Impairment MedDRA version: 9.1 Level: LLT Classification code 10009846 Term: Cognitive impairment
Conditions
Interventions
Product Code: V0191
Pharmaceutical Form: Oral solution
Current Sponsor code: V0191
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1500-
Pharmaceutical form of the
Sponsors
PIERRE FABRE MEDICAMENT - IDPF
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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, - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Changes in the scores obtained for the following neuropsychological tests at 12 and 24 weeks between the two groups will be analysed in no particular predefined order: - California Verbal Learning Tests, - DMS48 (visual recognition memory task), - Benton visual retention test, - Category Verbal Fluency Test, - Trail making test A and B, - Digit symbol substitution test: DSST, - Apathy unventory (accompanying person, patient and caregiver scores), - ADAS-cog, - CDR, - ADCS-ADL/MCI, - CGI (severity and improvement evaluated by the investigator), - global improvement evaluated by the patient.;Main Objective: To evaluate memory and cognitive performance in patients with Mild Cognitive Impairment of the Alzheimer type, after 6 months treatment with V0191. ;Secondary Objective: - to evaluate the effect on activities of daily living, - to evaluate the global clinical improvement perceived by the patient and assessed by the investigator, - to evaluate the safety and tolerability of the product. | — |
Countries
Austria, Belgium, Finland, France, Spain
Outcome results
None listed