E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild Cognitive Impairment |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009846 |
E.1.2 | Term | Cognitive impairment |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate cognitive improvement in patients with Mild Cognitive Impairment of the Alzheimer type, after 6 months treatment with V0191.
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E.2.2 | Secondary objectives of the trial |
- to evaluate memory improvement, - 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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, * absence 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, - if stipulated by national regulatory requirements, patient covered by a social security or health insurance system. |
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E.4 | Principal 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 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, - 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, - patients re"ceiving treatment with prohibited medication during the study period,
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 circle, - 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, - non-menopausal women.
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison between the 2 groups of the percentage of patients with a decrease on the ADAS-cog score of 4 points or greater compared with baseline. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is the date of the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |