Trial record 8 of 10 for:
Longeveron
Lomecel-B Effects on Alzheimer's Disease (CLEARMIND)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05233774 |
Recruitment Status :
Completed
First Posted : February 10, 2022
Last Update Posted : February 20, 2024
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Sponsor:
Longeveron Inc.
Collaborator:
bioRASI, LLC
Information provided by (Responsible Party):
Longeveron Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | December 16, 2021 | ||||
First Posted Date ICMJE | February 10, 2022 | ||||
Last Update Posted Date | February 20, 2024 | ||||
Actual Study Start Date ICMJE | December 28, 2021 | ||||
Actual Primary Completion Date | September 29, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Lomecel-B Effects on Alzheimer's Disease | ||||
Official Title ICMJE | Lomecel-B Effects on Alzheimer's Disease: A Randomized, Double-Blinded, Placebo-Controlled Phase 2a Trial | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: The study consists of 4 study arms of 12 patients each. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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Condition ICMJE | Mild Alzheimer's Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE |
48 | ||||
Actual Study Completion Date ICMJE | September 29, 2023 | ||||
Actual Primary Completion Date | September 29, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 60 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05233774 | ||||
Other Study ID Numbers ICMJE | 00-007-01 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Longeveron Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Longeveron Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | bioRASI, LLC | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Longeveron Inc. | ||||
Verification Date | February 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |