A Randomized, 24-week Parallel-group Placebo-controlled Multicenter (Phase 2) Study of Anthocyanins in People at Risk for Dementia
试验速览
- 阶段
- 不适用
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Quality of episodic memory.
研究概览
简要总结
The aim of this project is to study the safety and efficacy of anthocyanins in improving key dementia-related mechanisms and cognitive functioning in older people at risk for dementia. Secondary analyses will include a variety of biological measures, including biochemistry, imaging and cardiovascular measures.
详细描述
Design, Method, Material. Design: This is a randomized, 6-month, placebo-controlled Phase 2 study of anthocyanins (Medox) in people with increased risk for dementia, to explore the effects of anthocyanins on cognitive performance and a range of biological markers including blood markers of inflammation and oxidative stress, antioxidants, lipid profile, urine, faeces, and cardiovascular functions.
Method: Patients will be randomized (by means of a computerized program) to identically appearing capsules with Medox or placebo, 1:1 (produced by MedPalett). Patients will undergo monthly cognitive testing online. Brain MRI, structural and functional, will be performed before study start and at week 24. FDG-PET will also be done at sudy-start and study-end in a sub-group. Blood samples for analyses will be drawn at study start, after 12 weeks and at study end (week 24). Lumbar puncture for cerebrospinal fluid (CSF) analyses, and faeces analyses and urine will be done at study-start and study end, and additionally at week 12 for feces and urine. Cardiovascular test inlude cardio ankle vascular index (CAVI), and photopletysmography (PPG) measurements will be done at study start (baseline) week 2, 6, 12 and at study end (week 24). In a sub-group Flow mediated dilatation of brachial artery (FMD) will be done at study start, week 12 and study end.
The cognitive assessment battery consists of the CogTrack, an online cognitive test battery with proven utility, reliability, sensitivity and validity and sensitivity to change. The battery consists of ten subtests, which, based on factor analysis, are combined into the following domains: attention, memory and cognitive speed. The 15 word lists of the verbal memory test have been translated into Norwegian. The primary outcome measure will be the Quality of Episodic Memory combination of 2 accuracy scores from each of immediate and delayed word recall, word and picture recognition (4 tasks in total), which has been shown to be sensitive to cognitive changes . The battery will be administered online monthly at home, or with assistance from a research associate at SESAM/local research site if Internet is not available at home. Collection and registration will be performed securely online.
Patients will be tested at the same time of day on all occasions, usually in the morning. Testing procedures will be standardized (i.e. temperature, room, research associate, coffee intake).
Protocol amendment 17.08.20 Study: A randomized, 24-week parallel-group placebo-controlled multicenter (Phase 2) study of anthocyanins in people at risk for dementia.
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
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On none, or stable medication for the past three months AND
- •Mild cognitive impairment (MCI) according to Winblad OR
- •having >2 of the following conditions known to be associated with increased risk of cognitive impairment and dementia:
- •stable cardiovascular disease defined as coronary artery disease (CAD) seen on angiogram
- •cerebrovascular disease according to MRI criteria (i.e. presence of: Fazekas score >2 points OR cerebral infarct (>1 lesion) OR lacunar infarct (>1 lesion) OR lobar microbleed (>1 lesion), as judged by a qualified neuroradiologist) OR as visualized on CT scan for those having contraindications to MRI.
- •hypercholesterolemia/significant cardiovascular risk, operationalized as use of statin at baseline
- •hypertension, operationalized as previous diagnosis of arterial hypertension and/or use of antihypertensive drugs
- •diabetes mellitus type 1
- •metabolic syndrome including overweight (BMI>25) and diabetes mellitus type 2 (i.e. history of - and/or use of oral antidiabetic drugs and/or HbA1c >6.5%)
排除标准
- •Any dementia (defined as CDR >0.5)
- •Other known relevant brain disease such as Parkinson's disease, normal pressure hydrocephalus and other diseases which according to the study physician may cause cognitive decline
- •Clinically significant depression, i.e. major depression or GDS-15 score > 7
- •Unstable coronary heart disease
- •Heart failure in need of treatment
- •Systemic inflammatory diseases
- •Other serious disease with expected survival <5 years
- •Somatic disease that might affect cognitive function adversely
- •Usage of heparin, warfarin and Non-Vitamin K Antagonist Oral Anticoagulants (NOAC)
- •Any use of Medox during the 12 months prior to inclusion
结局指标
主要结局
Quality of episodic memory.
时间窗: Baseline to 24 weeks
A composite measure from the CogTrack battery
次要结局
- Cardiovascular parameters(Baseline to 24 weeks)
- Fecal analysis(Baseline to 24 weeks)
- Urine analysis(Baseline to 24 weeks)
- Secondary endpoints from CogTrack(Baseline to 24 weeks)
- Blood outcome analysis(Baseline to 24 weeks)
- CSF measurements(Baseline to 24 weeks)
- MR-imaging/CT(Baseline to 24 weeks)