💬In plain words
What the trial is, and whether it could suit you
The overall aim of MITO-AD is to evaluate if the nutritional supplement urolithin A is associated with favourable changes in Alzheimer's disease-related biomarkers, cognitive measures, and safety/tolerability outcomes in symptomatic patients with early-stage, biomarker-defined Alzheimer's disease. To do this, we will use two groups: one will be given standard care plus the food supplement urolithin A (the test group), and the other will be given just standard care plus a placebo (the control group). To measure potential differences between the groups, we will:
* Do clinical and neuropsychological assessments at baseline and follow-up visits, with main biomarker sampling at baseline, week 24, and week 48. (Additional safety, tolerability, compliance, and questionnaire-based assessments will be performed during the study.)
* Test blood samples from these patient groups for differences in
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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