NCT05233774

Lomecel-B Effects on Alzheimer's Disease

Lomecel-B Effects on Alzheimer's Disease: A Randomized, Double-Blinded, Placebo-Controlled Phase 2a Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Longeveron Inc. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Mild Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Allogeneic MSC	An allogeneic bone marrow-derived medicinal signaling cell (MSC) formulation
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-12-28
• Primary completion: 2023-09-29
• Completion: 2023-09-29
• First posted: 2022-02-10
• Last updated: 2024-02-20

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study