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

Zaparackas and Knepper LTD

Status and phase: Not yet enrolling; Phase 2

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Cognitive Decline

Treatments: Drug: Resveratrol, Quercetin, and Curcumin (RQC); Drug: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT06470061

ZK-01-2024

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Resveratrol, Quercetin, and Curcumin (RQC)

Experimental group

Description:

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

Treatment:

Drug: Resveratrol, Quercetin, and Curcumin (RQC)

Curcumin

Placebo Comparator group

Description:

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

Treatment:

Drug: Curcumin