RQC for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

Overseen byPaul A Knepper, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Zaparackas and Knepper LTD

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

Adults aged 50-90 with early-stage Alzheimer's (Stage 1 or 2) are eligible for this trial. They should be able to take oral supplements and undergo eye scans using OCT. People with other serious health issues, those who can't follow the study protocol, or those allergic to the supplements' ingredients cannot participate.

Inclusion Criteria

My gender or race does not limit my participation.

Ability to speak, read, and understand English

Have adequate literacy, vision, and hearing for neuropsychological testing at screening

+4 more

Exclusion Criteria

CDR-SB score > 0, indicating functional impairment

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)

I have been diagnosed with a type of mild cognitive impairment or dementia that is not Alzheimer's.

+6 more

Participant Groups

The trial is testing if a combination of resveratrol, quercetin, and curcumin (RQC), taken orally for two years, can prevent brain and eye changes linked to Alzheimer's. It will compare RQC's effects on cognitive function and retinal amyloid-β against curcumin alone.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Resveratrol, Quercetin, and Curcumin (RQC)Experimental Treatment1 Intervention

Resveratrol, Quercetin, and Curcumin (RQC) galactomannan formulations taken orally twice daily for 24 months.

Group II: CurcuminPlacebo Group1 Intervention

Curcumin taken orally twice daily during the 7 days preceding each study visit in order to label retinal amyloid-β.