A Randomized Phase II Study to Evaluate Oral RQC for the Prevention of Alzheimer's Disease and Retinal Amyloid-β
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Retinal Amyloid-β
研究概览
简要总结
The goal of this clinical trial is to evaluate whether oral resveratrol, quercetin, and curcumin (RQC) can prevent the accumulation of retinal amyloid-β and/or cognitive decline over 24 months in adults aged 50-90 with Stage 1 or 2 Alzheimer's disease as described in FDA-2013-D-0077. The trial will also evaluate the safety and tolerability of RQC. Curcumin, which binds to amyloid-β, will act as a fluorescent label to identify retinal amyloid-β in vivo using optical coherence tomography (OCT)-autofluorescence imaging. The investigators will longitudinally evaluate the effect of RQC on retinal amyloid-β load cognitive outcomes including the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and the Mini Mental State Examination (MMSE), and potential microvascular biomarkers. The investigators will also evaluate associations between retinal amyloid-β and progression to early Alzheimer's disease (mild cognitive impairment). The investigators will compare RQC, taken daily for 24 months, with curcumin alone, taken only during the 7 days preceding each of the six study visits to see if RQC can prevent (or reduce) amyloid-β and prevent the onset of mild cognitive impairment.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50-90 years of age at screening.
- •Male or female
- •Any race or ethnicity.
- •Provide written informed consent.
- •Availability for the duration of the study.
- •Ability to speak, read, and understand English.
- •Ability to take oral medication and be willing to adhere to the RQC regimen.
- •Have adequate literacy, vision, and hearing for neuropsychological testing at screening
排除标准
- •MMSE score 0-25, indicating more than subtle cognitive abnormalities
- •CDR-SB score > 0, indicating functional impairment
- •Clinical diagnosis of any non-Alzheimer's disease (AD) type of mild cognitive impairment (MCI) or dementia
- •Taking pharmaceutical anti-Aβ monoclonal antibodies (i.e., Leqembi, Aduhelm).
- •Participation in another clinical study with an investigational product during the last 90 days.
- •Presence of hepatic disease or kidney disease
- •Clinically significant or unstable hematologic, cardiovascular, pulmonary, gastrointestinal, endocrine metabolic, or other systemic disease.
- •Diagnosis of gastrointestinal or stomach condition including but not limited to irritable bowel syndrome (IBS), ulcerative colitis, peptic ulcers, Crohn's disease, gastroesophageal reflux disease, gastritis, severe dyspepsia, and intestinal malabsorption.
- •Clinically significant abnormal values in hematology, coagulation and platelet function, clinical chemistry, or urinalysis at screening (such as those with prolonged prothrombin time (PT), anemia, low neutrophil or platelet count, elevated liver function tests, low glomerular filtration rate).
研究组 & 干预措施
Resveratrol, Quercetin, and Curcumin (RQC)
Resveratrol, Quercetin, and Curcumin (RQC) galactomannan formulations taken orally twice daily for 24 months.
干预措施: Resveratrol, Quercetin, and Curcumin (RQC) (Drug)
Curcumin
Curcumin taken orally twice daily during the 7 days preceding each study visit in order to label retinal amyloid-β.
干预措施: Curcumin (Drug)
结局指标
主要结局
Change in Retinal Amyloid-β
时间窗: Baseline to 12 Months, Baseline to 24 Months
Retinal amyloid-β is identified using optical coherence tomography (OCT)-autofluorescence imaging and measured using a composite score called the retinal amyloid index (RAI), a continuous variable incorporating number, total area, and total fluorescence intensity of retinal Aβ spots. The change in RAI scores will be compared between RQC and control groups using linear mixed-effects models for repeated measures.
次要结局
- Progression to Clinically Relevant Cognitive Decline (MMSE)(Baseline to 12 Months, Baseline to 24 Months)
- Progression to Clinically Relevant Cognitive Decline (CDR-SB)(Baseline to 12 Months, Baseline to 24 Months)
- Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score(Baseline to 12 Months, Baseline to 24 Months)
- Change in Superactivated Platelet (SAP) Percentage(Baseline to 12 Months, Baseline to 24 Months)
- Correlation Between Change in Retinal Amyloid-β and Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score(Baseline to 12 Months, Baseline to 24 Months)
- Correlation Between Change in Retinal Amyloid-β and Change in Mini Mental State Examination (MMSE) Score(Baseline to 12 Months, Baseline to 24 Months)
- Change in Mini Mental State Examination (MMSE) Score(Baseline to 12 Months, Baseline to 24 Months)
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline, 12 Months, 24 Months)