Phase IIa Alzheimer’s therapy trial meets primary efficacy endpoints : Longeveron

Longeveron has reported that the Phase IIa CLEAR MIND trial of Lomecel-B for mild Alzheimer’s disease successfully met its primary safety and secondary efficacy endpoints. The randomized, placebo-controlled trial involved 48 participants aged 60 to 85 years.

Lomecel-B was found to potentially slow disease progression and was safe for both single and multiple doses, with no hypersensitivity, infusion-related reactions, or amyloid-related imaging abnormalities (ARIA) reported.

Patients treated with Lomecel-B experienced a slower rate of disease worsening compared to those receiving a placebo. Improvements were observed in the Composite Alzheimer’s Disease Score (CADS), including cognitive, functional, and MRI measures. Significant results were noted in the Montreal Cognitive Assessment, with trends showing better outcomes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and Mini-Mental State Examination (MMSE). The Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale also showed significant improvement. The FDA has granted Lomecel-B regenerative medicine advanced therapy and fast-track designations.