Randomized Controlled Trial to Evaluate the Efficacy of a Food Supplement, in Subjects With Mild Cognitive Impairment (MCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Memormax efficacy on global cognitive performance (FCRST).
研究概览
简要总结
This is a single-center, randomized, double-blinded placebo for the first 6 months of treatment in subjects with mild cognitive impairment. Open-label treatment, with all subjects receiving active treatment, for the next 6 months of study.
详细描述
Patients are enrolled in the department of Geriatria, Azienda Ospedaliera di Perugia. The group of this pilot project will include 50 subjects. All the volunteers who, in compliance with the inclusion and exclusion criteria, will be available for follow-up at twelve months and are able to give informed written consent guaranteeing adherence to the treatment will be enrolled in the study.
The study involves the collection of clinical data acquired as part of routine assessments for the type of subject included in this research project.
Visit 1 baseline: day 1 (time 0) Upon enrollment, all subjects, for whom informed consent will be obtained, will undergo a medical examination for an overall assessment of the state of health. In all subjects, a careful family, pathological and pharmacological anamnesis will be collected, data on the habits of life (nutrition, smoking, exercise) will be collected through a specific questionnaire and the main anthropometric parameters will be evaluated (weight, height,body mass index, waist / hip ratio) and the risk of development of cognitive impairment through the Brief Late-life Dementia Risk Index (Barnes et al., 2014).
The clinical examination will be completed by a standard assessment for the hematobiochemical and urinalysis examinations.
The results of the tests and of the tests carried out for the diagnosis of MCI, according to the clinical practice of the center, will be collected and used as baseline values, up to one month before entry into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind from Day 0 to Day 180. Open Label from Day 181 to Day 360.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with mild cognitive impairment, according to operational criteria for defining Mild Cognitive Impairment (MCI) (Albert et al, 2011): change in cognitive status, mild deficit in one or more cognitive domains, normal ability to perform activities in daily life or slight deficits not related to cognitive reasons, absence of dementia;
- •Good level of functional autonomy: ADL ≥ 5 / 6, IADL ≥ 4 / 8 for male subjects, ≥ 6/8 for female subjects, SPPB with score ≥ 9; Walk speed test in 6 meters ≥ 1 m / s;
- •Written informed consent of the patient.
排除标准
- •Subjects with malignant neoplasia in progress or diagnosed within 5 years;
- •Subjects with active infections or autoimmune pathogenesis diseases (eg sclerosis, Chron, polymyalgia);
- •Subjects diagnosed with neurodegenerative disease in pharmacological treatment (eg Parkinson's disease)
- •Subjects with psychiatric conditions (eg psychosis, depression, schizophrenia)
- •Subjects in pharmacological treatment for urinary incontinence
- •Subjects with involuntary weight loss> 5 kg in the last twelve months;
- •Subjects with chronic renal failure ≥ stage III K-DOQI;
- •Subjects with clinically significant liver disease (AST / SGOT, ALT / SGPT> 2 upper limits)
- •Subjects with severe hearing, vision, speech or walking disabilities;
- •Geriatric Depression Scale (Geriatric Depression Scale)> 4 out of 15 items;
- •Consumption in the two months prior to the baseline assessment of supplements containing omega-3 fatty acids or foods containing fish oil, foods for special medical purposes (AFMS);
- •Use in the month prior to baseline assessment of: atropine, scopolamine, tolterodine, iosciamin, biperidene, benzotropin, oxybutynin, antipsychotics, vitamins B, C and / or> at 200% of the suggested daily dose, highly energetic nutritional supplements and / or proteins, other products under experimentation;
- •Alcohol abuse.
- •Use of antibiotics in the two months preceding the baseline assessment;
- •Regular use of probiotics, fiber supplements or laxative
结局指标
主要结局
Memormax efficacy on global cognitive performance (FCRST).
时间窗: Day 0-180
Effect of Memormax on global cognitive performance in patients with mild Mild Cognitive Impairment (MCI) after a 6 months treatment and compared to placebo (T0-T6), measured by the FREE AND CUED SELECTIVE REMINDING TEST (FCRST)
Effect of Memormax on global cognitive performance across the entire population (FCRST)
时间窗: Day 181-360
To evaluate the effect of Memormax on global cognitive performance across the entire population studied in a 6-month open-label extension phase (T6-T12), measured by the FCSRT
Memormax efficacy on global cognitive performance (ACE-R).
时间窗: Day 0-180
Effect of Memormax on global cognitive performance in patients with mild Mild Cognitive Impairment (MCI) after a 6 months treatment and compared to placebo (T0-T6), measured by the ADDENBROOKE'S COGNITIVE EXAMINATION (ACE-R) tests.
Effect of Memormax on global cognitive performance across the entire population (ACE-R)
时间窗: Day 181-360
To evaluate the effect of Memormax on global cognitive performance across the entire population studied in a 6-month open-label extension phase (T6-T12), measured by the ACE-R
次要结局
- variations of the main parameters of cognitive performance (Rey Test)(Day 0-180-360)
- variations of physical performance ( timed up and go)(Day 0-180-360)
- variations of the main parameters of cognitive performance (Digit Span)(Day 0-180-360)
- variations of the main parameters of cognitive performance (Trail Making)(Day 0-180-360)
- variations of the main parameters of cognitive performance (Verbal Fluency)(Day 0-180-360)
- variations of the main parameters of cognitive performance (Babcock)(Day 0-180-360)
- variations of the main parameters of cognitive performance (Raven Test)(Day 0-180-360)
- variations of the main parameters of cognitive performance (Token Test)(Day 0-180-360)
- variations of physical performance (hand grip)(Day 0-180-360)
- variations of physical performance (SPPB)(Day 0-180-360)
- variations of the main parameters of cognitive performance (MMSE)(Day 0-180-360)
- variations of the main parameters of cognitive performance (NEPSY-II)(Day 0-180-360)
- variations of the main parameters of cognitive performance (GDS)(Day 0-180-360)
- variations of the main parameters of cognitive performance (NPI)(Day 0-180-360)
- variations of the main parameters of cognitive performance (Cognitive Reserve Index)(Day 0-180-360)
- variations of physical performance (BIA)(Day 0-180-360)
- variations of modification of oxidative stress conditions parameters.(Day 0-180-360)
- variations of physical performance (ADL)(Day 0-180-360)
- variations of physical performance (IADL)(Day 0-180-360)
- variations of modification of biochemical parameters of inflammation.(Day 0-180-360)
- variations of physical performance (Frailty index)(Day 0-180-360)
- variations of changes in the microbiota (bacteria subpopulations)(Day 0-180-360)
- variations of changes in the microbiota (SCFA)(Day 0-180-360)
- Safety and Tolerability (Adverse Events)(Day 0 to Day 360)