RQC for Alzheimer's Disease

Overseen By Nicholas M Pfahler

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zaparackas and Knepper LTD

Must not be taking: Anti-Aβ antibodies

Disqualifiers: Cognitive impairment, Hepatic disease, Kidney disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 24 months

200 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you do not take pharmaceutical anti-amyloid-β monoclonal antibodies like Leqembi or Aduhelm. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

How does the drug RQC differ from other Alzheimer's treatments?

RQC may be unique in its approach by targeting the kynurenine pathway, which is overactivated in Alzheimer's disease, and potentially reducing the effects of quinolinic acid, a compound that contributes to the disease by promoting tau phosphorylation and excitotoxicity. This mechanism is different from other treatments that primarily focus on amyloid plaques or neurotransmitter regulation. ^{1 2 3 4 5}

Research Team

Paul A Knepper, MD, PhD

Principal Investigator

Northwestern University

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Resveratrol, Quercetin, and Curcumin (RQC) daily for 24 months, with curcumin alone taken during the 7 days preceding each of the six study visits

24 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Curcumin
• RQC

Trial Overview 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.

Participant Groups

Group I: Resveratrol, Quercetin, and Curcumin (RQC) Experimental Treatment 1 Intervention

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

Group II: Curcumin Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Zaparackas and Knepper LTD

Lead Sponsor

Trials

1

Recruited

200+

Northwestern University Feinberg School of Medicine

Collaborator

Trials

42

Recruited

15,500+

References

1. United States pubmed.ncbi.nlm.nih.gov

The excitotoxin quinolinic acid induces tau phosphorylation in human neurons. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Increased hippocampal quinone reductase 2 in Alzheimer's disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Loss of quinone reductase 2 function selectively facilitates learning behaviors. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Increased quinolinic acid in peripheral mononuclear cells in Alzheimer's dementia. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Association of the Protein-Quality-Control Protein Ubiquilin-1 With Alzheimer's Disease Both in vitro and in vivo. [2022]