The Effect of Urolithin A (Mitopure®) on Alzheimer's Disease

NCT ID
NCT07842146
Registry status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University Hospital, Akershus
Conditions
Alzheimer's Disease (AD), Early Alzheimer's Disease, Mild Cognitive Impairment Due to Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: A Phase II Clinical Trial on the Effect of a Mitophagy Inducer Urolithin A on Alzheimer's Disease

Enrollment: 60 participants (Estimated).

What is being studied

  • Intervention: 3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one
  • Dietary supplement: Placebo Control
  • Dietary supplement: Urolithin A

Who may be eligible

Ages
55 Years to 85 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Czechia

Sample of listed locations

  • Second Faculty of Medicine, Charles University — Prague, 150 06, Czechia — Site recruitment status not specified in the registry data

Study details

Start date
October 15, 2026
Primary completion date
October 15, 2028
Completion date
October 15, 2028
First posted
September 25, 2026
Collaborators
Alzheimer's Association, Charles University, Czech Republic

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07842146
Registry last updated
September 25, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07842146 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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