No phaseRecruiting
The Effect of Urolithin A (Mitopure®) on Alzheimer's Disease (Mito-AD)
A Phase II Clinical Trial on the Effect of a Mitophagy Inducer Urolithin A on Alzheimer's Disease
- Sponsor
- University Hospital, Akershus (Academic or other)
- Enrolment
- 60 planned
- Conditions
- Alzheimer's Disease (AD); Early Alzheimer's Disease; Mild Cognitive Impairment Due to Alzheimer's Disease
- Interventions
- Urolithin A; Placebo Control
- Ages
- adults, older adults
- Registry
- NCT07842146
From the registry
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…
Primary outcomes
- Mean between-group differences in plasma p-Tau217