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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 is a Phase 2 study that has completed, run by Longeveron. The registered enrollment target is 50 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05233774
The ClinicalTrials.gov registry entry for NCT05233774 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Longeveron, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05233774 reports 0 study locations.
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.
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