Comparative Randomized Clinical Trial of the Efficacy of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment and APOE ε4 Carriers
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in ADAS-COG
研究概览
简要总结
A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. The first group will receive treatment with Cannabidiol 5%, the second group will receive treatment with Vivimind and the third group will not receive any treatment. The three groups will be compared by using an extensive neuropsychological examination and biomarkers' results from cerebrospinal fluid and blood
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Mild Cognitive Impairment
- •Carry APOE ε4 gene
排除标准
- •Diagnosis of Dementia
- •Patients who receive medication for memory or depression
- •Patients who do not carry APOE ε4 gene
研究组 & 干预措施
Group receiving Cannabidiol
These patients will receive cannabidiol 5% without other medication for cognition and depression
干预措施: Cannabidiol Oil (Drug)
Group receiving Homotaurine
These patients will receive Vivimind (homotaurine) without other medication for memory and depression
干预措施: Homotaurine (Drug)
结局指标
主要结局
Changes in ADAS-COG
时间窗: 12-24 months
Measurement of general cognitive function
Changes in Rey Auditory Verbal Learning Test
时间窗: 12-24 months
Screening tool to assess verbal memory and learning
Changes in Rey Osterrieth Complex Figure
时间窗: 12-24 months
Screening tool to assess visuospatial memory
Changes in Functional Rating Scale for Dementia
时间窗: 12-24 months
Measurement of daily functionality
Changes in Clinical Dementia Rating Scale score
时间窗: 12-24 months
Measurement of general cognitive function
Changes in Functional Cognitive Assessment (FUCAS) score
时间窗: 12-24 months
Measurement of daily functionality
Changes in Letter & Category Verbal Fluency
时间窗: 12-24 months
Measurement of verbal fluency, learning, long term memory and categorization skills
Changes in Trail Making Test A & B
时间窗: 12-24 months
Screening tool to assess working memory and processing speed
Changes in Geriatric Depression Scale
时间窗: 12-24 months
Screening tool to assess depressive symptoms
Changes in SAST
时间窗: 12-24 months
Screening tool to assess anxiety
Changes in Montreal Cognitive Assessment (MoCA) score
时间窗: 12-24 months
Screening test to assess general cognitive function
Changes in Mini Mental State Examination (MMSE) score
时间窗: 12-24 months
Changes in Beck Anxiety Inventory
时间窗: 12-24 months
Screening tool to assess anxiety
Changes in Rivermead Behavioural Memory Test
时间窗: 12-24 months
Screening tool to assess episodic memory and learning
Changes in STROOP Test
时间窗: 12-24 months
Measurement of selective attention and cognitive flexibility
Changes in Symbol-Digit Test
时间窗: 12-24 months
Measurement of processing speed, learning and working memory
Changes in BDNF
时间窗: 12-24 months
Cerebrospinal Fluid Biomarker
Changes in MDA
时间窗: 12-24 months
Cerebrospinal Fluid Biomarker
Changes in GFAP
时间窗: 12-24 months
Cerebrospinal Fluid Biomarker
Changes in Tau-protein
时间窗: 12-24 months
Cerebrospinal Fluid Biomarker
次要结局
未报告次要终点
研究者
Magda Tsolaki
Professor of Neurology, Medical School, Aristotle University of Thessaloniki
Aristotle University Of Thessaloniki