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Life sciences · Interventional Study
ClinicalTrials.gov · September 25, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07842146). This is a study registration, not published results. Lead sponsor: University Hospital, Akershus. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Alzheimer's Disease (AD), Early Alzheimer's Disease, Mild Cognitive Impairment Due to Alzheimer's Disease. Interventions: DIETARY_SUPPLEMENT: Urolithin A; DIETARY_SUPPLEMENT: Placebo Control. Primary outcome measures: Mean between-group differences in plasma p-Tau217 , Baseline and Week 48.. Brief summary: 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 various biomarkers to assess biological differences between them, and * Test cerebrospinal fluid (CSF) from a voluntary sub-cohort who will undergo CSF sampling at baseline and Week 4 to assess urolithin A exposure. N.B. Both groups will continue standard-of-care symptomatic Alzheimer's disease treatment as prescribed by the treating physician (where applicable). Standard of care may include acetylcholinesterase inhibitors and/or memantine. Participants receiving standard symptomatic Alzheimer's disease treatment must have been on a stable dose for at least 8 weeks prior to screening. Participants receiving anti-amyloid disease-modifying therapy will not be enrolled