The parallel design, four-arm, randomised clinical trial will assess the safety of single and multiple infusions of two different Lomecel-B dose levels compared to a placebo in mild AD patients.
It will be conducted in 48 participants.
The study’s primary endpoint is to assess the safety of Lomecel-B by measuring the occurrence of serious adverse events (SAEs) in the initial 30 days after giving the investigational therapeutic candidate.
Brain volumetry by magnetic resonance imaging (MRI), measures of cognitive function, and biomarkers relevant to inflammation and endothelial/vascular systems are some of the secondary and exploratory endpoints of the study.
The company stated that the Phase IIa CLEAR MIND trial follows the previously announced positive results of the Phase Ib clinical trial of Lomecel-B for AD.
The findings demonstrated that the therapeutic candidate met the trial’s primary endpoint of safety.
Longeveron interim CEO and chief medical officer Chris Min said: “We are pleased to have completed enrolment in our Phase IIa study of Lomecel-BTM for Alzheimer’s Disease.
“We look forward to building on our Phase Ib study, which met its primary endpoint of safety and was published in a leading journal, Alzheimer’s and Dementia, the Journal of the Alzheimer’s Association, this year.
“We are excited to advance our programme designed to assess the therapeutic potential of Lomecel-BTM in patients with AD.”
Lomecel-B is currently being assessed in several clinical trials for the treatment of ageing-related chronic diseases, as well as other life-threatening conditions under the Investigational New Drug (IND) applications, which are approved by the US Food and Drug Administration (FDA).