Phase 2Completed
Lomecel-B Effects on Alzheimer's Disease (CLEARMIND)
Lomecel-B Effects on Alzheimer's Disease: A Randomized, Double-Blinded, Placebo-Controlled Phase 2a Trial
- Sponsor
- Longeveron Inc. (Industry)
- Enrolment
- 50 enrolled
- Conditions
- Mild Alzheimer's Disease
- Interventions
- Allogeneic MSC; Placebo
- Ages
- adults, older adults
- Registry
- NCT05233774
From the registry
Dementia resulting from AD is associated with vascular function decline and involves a pro-inflammatory state. In our Phase 1 trial, Lomecel-B treatment met the primary safety endpoint, with no safety concerns, and showed potential to improve clinical assessments. Mechanistically, Lomecel-B treated subjects had higher serum concentrations of pro-vascular and anti-inflammatory biomarkers relative to placebo. This trial builds upon those preliminary Phase 1 results, and is designed to evaluate the safety profile of multiple infusions of Lomecel-B, and to investigate provisional efficacy of single dosing versus multiple dosing of Lomecel-B on cognitive function and biomarkers in AD subjects.
Primary outcomes
- Primary Endpoint 1: Safety - SAEs and AEs
- Primary Endpoint 2: Safety - Imaging