Urolithin A for early Alzheimer’s disease: a test with a nutritional supplement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II interventional study compares urolithin A to placebo in symptomatic adults aged 55–85 with biomarker-supported Alzheimer’s disease. Participants are randomized to receive either urolithin A plus standard care or placebo plus standard care, with follow-ups at baseline, 24 weeks, and 48 weeks. The study collects clinical and neuropsychological data, safety/tolerability information, and biological samples including blood and cerebrospinal fluid to examine AD biomarkers and mitophagy-related processes. Outcomes include changes in core AD biomarkers (e.g., p-Tau217), markers of inflammation and oxidative stress, and autophagy/mitophagy function, along with safety and compliance assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

IN-1. Participants must be between 55 and 85 years of age at the time of inclusion.

IN-2. Participants must meet the National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria for Alzheimer's disease (AD)

IN-3. Participants must have evidence of AD pathology, confirmed by either a positive amyloid PET imaging result or cerebrospinal fluid (CSF) biomarkers reflecting amyloid pathology (e.g., decreased Aβ42 levels or decreased Aβ42/40 ratio, and increased levels of p-Tau181, and total Tau)

IN-4. Participants must have a Mini-Mental State Examination (MMSE) score of ≥24.

IN-5. Participants must have been on stable doses of FDA-approved AD medications (e.g., cholinesterase inhibitors) for at least 8 weeks prior to screening

IN-6. Participants must possess adequate visual and auditory acuity to complete testing

IN-7. Participants must speak fluent Czech.

IN-8. Participants must have a reliable study partner.

IN-9. Participants must have the ability to provide written consent to participate.

IN-10. Participants must be capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

EX-1. Participants will be excluded if they do not have clinically diagnosed AD.

EX-2. Participants will be excluded if they have significant neurological conditions other than AD (e.g., Parkinson's disease, frontotemporal dementia, or vascular dementia), a history of head trauma with persistent neurological deficits, or baseline neuroimaging indicating cortical stroke or severe ischemic disease

EX-3. Participants will be excluded if they have suffered from psychiatric conditions such as major depressive disorder (within the past year), bipolar disorder, or schizophrenia will be excluded

EX-4. Participants will be excluded if they have had recent substance use disorder (past 2 years)

EX-5. Participants will be excluded if they have unstable systemic illnesses including hepatic or renal failure

EX-6. Participants will be excluded if they have decompensated diabetes

EX-7. Participants will be excluded if they are taking medications with anticholinergic effects

EX-8. Participants will be excluded if they are taking dietary supplements containing nicotinamide mononucleotide (NMN) or nicotinamide riboside (NR)

EX-9. Participants will be excluded if they have significant spinal disease complicating lumbar puncture or with anticoagulant therapy (only for the CSF group)

EX-10. Participants will be excluded if they have participated in another investigational trial within the past 3 months or have medical conditions that could jeopardise their safety or affect study results, as judged by the investigator

Where it's running

• Second Faculty of Medicine, Charles University
  Prague, Czechia Recruiting

Study contacts

• Principal investigator: Evandro Fei Fang-Stavem, PhD — Akershus University Hospital and University of Oslo
• Study coordinator: Shuqin Cao, PhD
• Email: shuqin.cao@medisin.uio.no
• Phone: +47 67 96 00 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.