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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Zaparackas and Knepper LTD
Study ID
NCT06470061
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Resveratrol, Quercetin, and Curcumin (RQC) — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
Jun 2024
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Resveratrol, Quercetin, and Curcumin (RQC)
    Resveratrol, Quercetin, and Curcumin (RQC) galactomannan formulations taken orally twice daily for 24 months.
  • Placebo Comparator: Curcumin
    Curcumin taken orally twice daily during the 7 days preceding each study visit in order to label retinal amyloid-β.

Primary Outcome Measure

Change in Retinal Amyloid-β [ Time Frame: Baseline to 12 Months, Baseline to 24 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zaparackas & Knepper Ltd.ChicagoIllinois60611
Stephanie Aman
[email protected]
312-337-1285
Zibute Zaparackas, MD
[email protected]
312-337-5165
Paul A Knepper, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Zaparackas & Knepper Ltd.· Chicago, IL

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