A Randomized Phase II Study to Evaluate Oral RQC for the Prevention of Alzheimer's Disease and Retinal Amyloid-β
Zaparackas and Knepper LTD
Summary
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.
Eligibility
- Age range
- 50–90 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * 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 (A…