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

NCT ID: NCT06470061

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2027-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Resveratrol, Quercetin, and Curcumin (RQC)

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

Group Type: EXPERIMENTAL

Resveratrol, Quercetin, and Curcumin (RQC)

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Curcumin

Intervention Type: 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.

Interventions

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)

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Resveratrol, Quercetin, and Curcumin

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University Feinberg School of Medicine

OTHER

Sponsor Role: collaborator

Zaparackas and Knepper LTD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul A Knepper, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Zaparackas & Knepper Ltd.

Chicago, Illinois, United States

Countries

United States

Central Contacts

Stephanie Aman

Role: CONTACT

knezap@sbcglobal.net

312-337-1285

Nicholas M Pfahler

Role: CONTACT

maxpfahler@gmail.com

773-677-0447

Facility Contacts

Stephanie Aman

Role: primary

knezap@sbcglobal.net

312-337-1285

Zibute Zaparackas, MD

Role: backup

z-zaparackas@northwestern.edu

312-337-5165

References

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Other Identifiers

ZK-01-2024

Identifier Type: -

Identifier Source: org_study_id