EUCTR2007-001975-12-BE进行中（未招募）不适用
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 个研究点目标入组 200 人开始时间: 2008年1月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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,
- •- 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
排除标准
- •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 product indicated for the symptomatic treatment of chronic neurosensory or cognitive pathological impairment in elderly subjects (Gingko biloba, almitrine, piracetam, etc.),
- •- patients receiving 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-menauposal women.
研究者
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