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RQC for the Prevention of Alzheimer's Disease and Retinal Amyloid-β
Sponsor: 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.
Official title: A Randomized Phase II Study to Evaluate Oral RQC for the Prevention of Alzheimer's Disease and Retinal Amyloid-β
Key Details
Gender
All
Age Range
50 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-07
Completion Date
2027-07
Last Updated
2024-06-26
Healthy Volunteers
Yes
Interventions
Resveratrol, Quercetin, and Curcumin (RQC)
2000 mg Curcumin/day, taken twice daily for 24 months (galactomannan formulation, capsule form) 334 mg Resveratrol/day, taken twice daily for 24 months (galactomannan formulation, capsule form) 60 mg Quercetin/day, taken twice daily for 24 months (galactomannan formulation, capsule form)
Curcumin
2000 mg Curcumin/day, taken twice daily for 7 days preceding each study visit (baseline and months 3, 6, 12, 18, and 24 for a total of 42 non-consecutive days over 24 months.
Locations (1)
Zaparackas & Knepper Ltd.
Chicago, Illinois, United States