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NCT05233774 · ClinicalTrials.gov registry record · Phase 2
Lomecel-B Effects on Alzheimer's Disease
A Phase 2 study, sponsored by Longeveron.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT05233774: Completed Phase 2 study, sponsored by Longeveron.
NCT05233774 is a Phase 2 study that has completed, run by Longeveron. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05233774, a Phase 2 study, has completed, sponsored by Longeveron.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
To demonstrate that Lomecel-B infusions do not trigger the pre-specified stopping rules. Additional safety will be acquired throughout the study as follows: Incidence of all AEs and SAEs over the course of the trial.
Interventions
- OTHER Placebo
- DRUG Allogeneic MSC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-12-28 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 2 |
What the finished NCT05233774 record still lists
NCT05233774 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05233774 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05233774 about?
NCT05233774 is a clinical study titled "Lomecel-B Effects on Alzheimer's Disease". 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 ...
What is the current status of trial NCT05233774?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2021-12-28. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT05233774?
The interventions under investigation include: Placebo (OTHER), Allogeneic MSC (DRUG).
Who is sponsoring clinical trial NCT05233774?
This trial is sponsored by Longeveron, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05233774's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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