Longeveron to present MRI biomarker data in Alzheimer’s at CTAD 2025

Longeveron (LGVN) announced that its submission entitled “Reduced brain neuroinflammation after laromestrocel treatment in mild AD: results from the CLEAR MIND study” is being presented in a poster presentation at the 18th Clinical Trials on Alzheimer’s Disease Conference being held December 1-4, 2025 in San Diego, CA. Longeveron has conducted phase 1 and 2 clinical trials testing laromestrocel as a potential therapeutic for mild AD and has received Regenerative Medicine Advanced Therapy designation from the US Food and Drug Administration for this clinical program. A hallmark feature of Alzheimer’s disease is neuroinflammation, which is a principal driving factor in disease pathogenesis, gliosis, and neuronal death. In the CLEAR MIND study, we demonstrated that laromestrocel treatment improved clinical scores and reduced brain atrophy in multiple brain regions, including the hippocampus as well as the temporal and frontal lobes. To extend these findings, we sought mechanistic evidence of an effect on neuroinflammation in core AD-associated regions, particularly the hippocampal and temporal regions. We examined the effects of laromestrocel treatment in patients of our CLEAR MIND Phase 2a trial on inflammation in the AD brain using diffusion tensor imaging and free water analysis. In DTI imaging, although mean diffusivity provides some indication of inflammation, free water is considered a more precise measure and is used in assessing hippocampal AD pathology, although no clinically meaningful difference in free water has yet been defined. Laromestrocel is a novel, bone marrow-derived, mesenchymal stem cell (MSC)-based investigational therapeutic that targets neuroinflammation, microvascular dysfunction, and has the potential to stimulate endogenous tissue regeneration, and has received RMAT and fast-track designations from the US FDA for mild AD. Patients receiving laromestrocel exhibited a durable reduction in free water fraction compared with placebo at week 39 for several brain regions, including hippocampus, which showed a dose response, and also temporal cortex, occipital cortex, and parietal cortex. This new result was accompanied by clinical benefit as wells as reduced brain atrophy, as demonstrated in our study. Of the 14 brain regions, 13 showed pooled treatment group responses in the direction of improvement by week 39. Overall, treatment with laromestrocel was associated with a reduction in neuroinflammation as assessed by free water compared to placebo across multiple brain regions, including key AD-associated regions-most notably in the hippocampus and temporal lobe. Importantly, rising free water was found in the placebo group, representing continued disease progression, while inflammation was stabilized with laromestrocel treatment. These findings suggest a sustained anti-inflammatory effect of laromestrocel, reinforcing its proposed mechanism of action in the treatment of mild Alzheimer’s disease. This evidence supports continued clinical development of laromestrocel for this indication.