NCT06470061

RQC for the Prevention of Alzheimer's Disease and Retinal Amyloid-β

A Randomized Phase II Study to Evaluate Oral RQC for the Prevention of Alzheimer's Disease and Retinal Amyloid-β

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Zaparackas and Knepper LTD · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Cognitive Decline

Interventions

Type	Name	Description
DRUG	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)
DRUG	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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2024-06-24
• Last updated: 2024-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study