Effectiveness of Genistein on the Progression of Cognitive Impairment in Patients With Mild Cognitive Impairment: Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cognitive function
研究概览
简要总结
Randomized, placebo-controlled, double-blind, multicenter clinical trial with two parallel study arms (experimental and placebo) to assess the efficacy of genistein extract consumption over 18 months on cognitive decline in patients with prodromal Alzheimer's disease.
详细描述
The study aims to evaluate the effect of genistein over 18 months compared to placebo on the progression of cognitive impairment in subjects diagnosed with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) in the following areas:
- Global assessment of dementia: overall evaluation of functionality and cognitive decline in MCI subjects.
- Global cognitive functions: assessment of general cognitive abilities.
- Episodic memory: evaluation of memory performance.
- Activities of daily living: assessment of the ability to perform basic and instrumental daily activities.
- Emotional and depressive state: evaluation of subjects' mood and depressive symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 50 years of age.
- •Patient diagnosed with mild cognitive impairment (MCI) for Alzheimer's disease (AD) according to the National Institute on Aging and Alzheimer's Association (NIA-AA, 2024) criteria:
- •MMSE scores between 22 and 30 (inclusive; exceptions may be made for subjects with less than 5 years of education).
- •Evidence of concern about change in cognition, compared to the person's previous level (subjective memory complaint/impairment for more than 6 months in the past year and/or confirmed by the informant and/or physician).
- •A Clinical Dementia Rating (CDR) score of 0.5 with a memory domain score of 0.
- •Essentially preserved activities of daily living.
- •Evidence of elevated cortical amyloid by positron emission tomography (PET) with F18-flutemetamol. • Patients will be treated pharmaceutically according to the guidelines.
排除标准
- •Diagnosis of a significant neurological disease other than Alzheimer's disease.
- •Moderate depression as assessed by a Geriatric Depression Scale (GDS-D) score >8, or any other serious psychiatric disorder.
- •Taking supplements containing isoflavones.
- •Having a hormone-dependent neoplastic disease.
- •Diagnosis of significant cerebrovascular disease.
- •Having a serious systemic illness that would prevent completion of the study.
研究组 & 干预措施
Placebo
The product will have the same characteristics as the experimental product.
干预措施: Control product placebo (Dietary Supplement)
Genistein
Subjects will consume two capsules daily. Each capsule will be taken before the two main meals, each 100 mg tablet.
干预措施: Genistein (Dietary Supplement)
结局指标
主要结局
Cognitive function
时间窗: From baseline to month 18
The primary variable to be evaluated is the change in overall cognitive function and the deterioration in the ability to perform activities of daily living, assessed through the mean change by the Integrated Alzheimer's Disease Rating Scale (iADRS) score. iADRS is an assessment tool designed to comprehensively measure cognitive and functional decline in patients with Alzheimer's disease, especially in the early stages. It combines elements of cognitive and functional assessment in a single scale, using ADAS-Cog and ADCS-ADL. In this case, version ADAS-Cog14 was used.
次要结局
- Detection and assessment of cognitive impairment(18 months)
- Assess symptoms of depression(18 months)
- Safety(18 months)
- Severity of dementia(18 months)
- global cognition(18 months)
- Assess functionality in patients with cognitive impairment(18 months)
- Activities of daily living(18 months)
- Assess verbal memory(18 months)
- Assess cognitive functions(18 months)
- visuospatial abilities and visual memory(18 months)
- Assess visual memory, visuospatial perception, and executive functions(18 months)
- Working memory and attention(18 months)
- Ability to generate words within a specific category(18 months)
- Assess executive functions(18 months)
- Knowing the amount of ß-amyloid (βA) plaques(18 months)
- Knowing the response to treatment(18 months)
- Comorbidities and Medication(18 months)
- Demographic variables(18 months)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia