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

This study is looking at whether a combination of Resveratrol, Quercetin, and Curcumin (RQC) can help prevent the buildup of a protein called amyloid-beta in the eye and slow down memory and thinking problems in people with early Alzheimer's disease. Researchers will also check how safe and well-tolerated RQC is. Curcumin will be used to help identify amyloid-beta in the eye using a special imaging technique. The study aims to enroll 200 adults between 50 and 90 years old who are in the early stages of Alzheimer's disease. The main goal is to see how RQC affects amyloid-beta in the eye over 12 and 24 months.

Study design
This is an interventional study planning to enroll 200 participants. The phase of the study is not specified.
What's involved
Participants will take oral medication (RQC or Curcumin alone) twice daily for 24 months. There will be study visits at baseline and months 3, 6, 12, 18, and 24.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 12 and 24 months, indicating follow-up for at least this duration.

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NCT06470061

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

Not Yet Recruiting
PHASE2Ages 50–90InterventionalPrevention
Zaparackas and Knepper LTD
~200 participants
Updated 2024-06-26 on ClinicalTrials.gov
What's tested:Resveratrol, Quercetin, and Curcumin (RQC)Curcumin

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Retinal Amyloid-β
Measured over Baseline to 12 Months, Baseline to 24 Months
Alzheimer Disease
Mild Cognitive Impairment
Cognitive Decline
1 sites across 1 states
Illinois1
  • Paul A Knepper, MD, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University

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Eligibility criteria

Inclusion

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

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 (AD) type of mild cognitive impairment (MCI) or dementia
Taking pharmaceutical anti-Aβ monoclonal antibodies (i.e., Leqembi, Aduhelm).
Participation in another clinical study with an investigational product during the last 90 days.
Presence of hepatic disease or kidney disease
Clinically significant or unstable hematologic, cardiovascular, pulmonary, gastrointestinal, endocrine metabolic, or other systemic disease.
Diagnosis of gastrointestinal or stomach condition including but not limited to irritable bowel syndrome (IBS), ulcerative colitis, peptic ulcers, Crohn's disease, gastroesophageal reflux disease, gastritis, severe dyspepsia, and intestinal malabsorption.
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).
  • Change in Retinal Amyloid-βBaseline to 12 Months, Baseline to 24 Months

    Retinal amyloid-β is identified using optical coherence tomography (OCT)-autofluorescence imaging and measured using a composite score called the retinal amyloid index (RAI), a continuous variable incorporating number, total area, and total fluorescence intensity of retinal Aβ spots. The change in RAI scores will be compared between RQC and control groups using linear mixed-effects models for repeated measures.