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Trial record 1 of 1 for:    Longeveron | Alzheimer Disease 2 | Miami, Florida, U.S.
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05233774
Recruitment Status : Recruiting
First Posted : February 10, 2022
Last Update Posted : August 16, 2022
Sponsor:
Collaborator:
bioRASI, LLC
Information provided by (Responsible Party):
Longeveron Inc.

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.

Condition or disease Intervention/treatment Phase
Mild Alzheimer's Disease Drug: Allogeneic MSC Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Official Title: Lomecel-B Effects on Alzheimer's Disease: A Randomized, Double-Blinded, Placebo-Controlled Phase 2a Trial
Actual Study Start Date : December 28, 2021
Estimated Primary Completion Date : September 29, 2023
Estimated Study Completion Date : September 29, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Group 1 will receive four infusions of Placebo on Day 0, Week 4, Week 8, and Week 12.
Other: Placebo
Placebo

Experimental: Lomecel-B Dose 1
Group 2 will receive an infusion of Lomecel-B at a dose of 25 x 10^6 cells (25M) on Day 0, followed by Placebo infusions at Week 4, Week 8, and Week 12.
Drug: Allogeneic MSC
An allogeneic bone marrow-derived medicinal signaling cell (MSC) formulation

Experimental: Lomecel-B Dose 2
Group 3 will receive four infusions of 25M Lomecel-B on Day 0, Week 4, Week 8, and Week 12.
Drug: Allogeneic MSC
An allogeneic bone marrow-derived medicinal signaling cell (MSC) formulation

Experimental: Lomecel-B Dose 3
Group 4 will receive four infusions of Lomecel-B at a dose of 100 x 10^6 cells (100M) on Day 0, Week 4, Week 8, and Week 12.
Drug: Allogeneic MSC
An allogeneic bone marrow-derived medicinal signaling cell (MSC) formulation




Primary Outcome Measures :
  1. Primary Endpoint 1: Safety - SAEs and AEs [ Time Frame: 41 weeks ]

    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.


  2. Primary Endpoint 2: Safety - Imaging [ Time Frame: 41 weeks ]

    To demonstrate that Lomecel-B infusions do not trigger the pre-specified stopping rules.

    Additional safety will be acquired throughout the study as follows: Alzheimer's disease-related imaging abnormalities (ARIA) or clinically asymptomatic microhemorrhages as revealed by MRI.



Secondary Outcome Measures :
  1. Secondary Endpoint 2: Efficacy- Change in the ADAS-cog-13 [ Time Frame: 41 weeks ]
    Change from baseline in the ADAS-cog-13 in Lomecel-B-treated arms versus change in placebo.

  2. Secondary Endpoint 3: Efficacy- Change in the MMSE [ Time Frame: 41 weeks ]
    Change from baseline in the MMSE in Lomecel-B-treated arms versus change in placebo.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent.
  • Be 60 - 85 years of age at signing of the Informed Consent Form.
  • Clinical diagnosis of mild Alzheimer's disease in accordance with the NIA-AA criteria at the time of enrollment.
  • MMSE score of 19 - 23.
  • Body weight of 40 - 150 kg.
  • Has an adult caregiver who meets all of the following criteria.

    1. Provides written informed consent to participate on the trial (reporting on patient observations).
    2. Either lives with the patient, or sees the patient for at least 2 hours/day for at least 3 days/week.
    3. Is willing and able to participate in the study, and agrees to accompany the patient to each study visit.
    4. Is able to read, understand, and speak the designated language at the study site.
  • Brain MRI consistent with AD.
  • A PET scan using an FDA-approved tracer (e.g., AMYViD, Vizamyl, or Neuraceq) consistent with the diagnosis of AD. A prior positive PET scan will be allowed with Sponsor approval.
  • Living in the community, includes assisted living facilities (but excluding long-term care nursing facilities).

Exclusion Criteria:

  • Diagnosed with frontotemporal dementia (FTD), dementia due to Acquired Immunodeficiency Syndrome (AIDS), Creutzfeldt-Jakob disease (CJD), Lewy Bodies dementia (LBD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions, or normal pressure hydrocephalus.
  • Any other neurodegenerative disease.
  • History of a seizure disorder.
  • Evidence of: a prior macrohemorrhage; at least 4 cerebral microhemorrhages (regardless of anatomical location or diagnostic characterization as "possible" or "definite"); or at least 1 area of superficial siderosis.
  • Unwillingness or inability to have MRIs scans (no contrasting agent will be used), or condition that contraindicates MRI, such as the presence metallic objects in the eyes, skin, or heart.
  • Any conditions that contraindicates PET with a beta-amyloid tracer.
  • Significant intestinal malabsorption surgery, e.g., gastric bypass.
  • Serum B12 and/or folate levels below normal range.
  • Clinically abnormal free T4 or thyroid-stimulating hormone (TSH).
  • Resting blood oxygen saturation <93%.
  • Resting systolic blood pressure >180 mm Hg, or diastolic blood pressure >110 mm Hg.
  • Regularly (> 4 weeks) using high-doses of corticosteroids or other steroidal anti-inflammatory medication (e.g., Prednisone) on a regular basis, with the exception of steroidal nasal sprays, asthma inhalers, topical steroids, and hormonal-replacement therapy.
  • Regularly (> 4 weeks) using anti-cytokine antibody or targeting therapy, e.g., anti-TNF-α.
  • Be an organ transplant recipient, or have active or expected future listing for any organ/tissue transplant while scheduled to be on trial, except for corneal, bone, skin, ligament, or tendon.
  • Diagnosed with malignancy within the past 2 years, with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ, or cervical carcinoma.
  • Known hypersensitivity to dimethyl sulfoxide (DMSO).
  • Test positive for hepatitis B virus surface antigen, viremic hepatitis C virus, HIV, or syphilis.
  • Any condition that is projected to limited life expectancy to < 12 months.
  • Be pregnant, nursing, or of childbearing potential while not practicing effective contraception.
  • Be currently participating in any other investigational therapeutic or device trial, or have participated within one within the previous 30 days to screening, or in the opinion of the investigator, the patient should be excluded for such participation within the past 5 years.
  • In the opinion of the investigator, the patient has any other illness or condition that: may compromise the participant's safety, compliance, or ability to successfully complete the study; may compromise the validity of the study; or otherwise should exclude the participant from enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05233774


Contacts
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Contact: Kevin N Ramdas, MD, MPH (786) 543-6793 ALZresearch@longeveron.com
Contact: Nana Yakoubov Regulatory_Affairs@biorasi.com

Locations
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United States, Florida
Visionary Investigators Network Recruiting
Aventura, Florida, United States, 33180
Contact: Wisline Fenelus    305-336-5713    wfenelus@vintrials.com   
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact: Yolanda Gonzalez    561-374-8461 ext 1141    ygonzalez@ergclinical.com   
Science Connections - Research Partner Group Multispecialty Group Not yet recruiting
Doral, Florida, United States, 33178
Contact: Maria Oliver    786-521-8103    molivera@scienceconnections.com   
Bruce W. Carter VA Medical Center Not yet recruiting
Miami, Florida, United States, 33125
Contact: Victor Cevallos    305-575-7000 ext 16993    Victor.Cevallos2@va.gov   
Miami Jewish Health Recruiting
Miami, Florida, United States, 33137
Contact: John Rodriguez    305-751-8626 ext 64104    jrodriguez4@miamijewishhealth.org   
Allied Biomedical Research Institute Not yet recruiting
Miami, Florida, United States, 33155
Contact: Luis Estevez    305-643-8400    lestevez@abriusa.net   
Ivetmar Medical Group Not yet recruiting
Miami, Florida, United States, 33155
Contact: Andrea Cabrera    754-800-9075    andrea.cabrera@ivetmar.com   
Fusion Medical Research and Clinic Recruiting
Miami, Florida, United States, 33173
Contact: Melissa Ocana    305-609-6464    melissaocana@yahoo.com   
First Excellent Research Group, LLC Recruiting
Miami, Florida, United States, 33175
Contact: Milka Vina    786-285-5631    mvina@firstexcellentresearch.com   
Brainstorm Research Recruiting
Miami, Florida, United States, 33176
Contact: Savannah Rodriguez    305-596-2080 ext 1112    srodriguez@brainstormresearch.net   
Contact: David Rasch    305-596-2080 ext 1111    drasch@brainstormresearch.net   
Miami Dade Medical Research Institute Not yet recruiting
Miami, Florida, United States, 33176
Contact: Stacy Machado    305-722-7210    smachado@miamimedresearch.com   
Imic Inc. Recruiting
Palmetto Bay, Florida, United States, 33157
Contact: Nikolas Boris    305-338-0568    boris@aktamedika.com   
Brain Matters Research Recruiting
Stuart, Florida, United States, 34997
Contact: Paula Kirk    772-223-7809    PKirk@ergclinical.com   
Sponsors and Collaborators
Longeveron Inc.
bioRASI, LLC
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Responsible Party: Longeveron Inc.
ClinicalTrials.gov Identifier: NCT05233774    
Other Study ID Numbers: 00-007-01
First Posted: February 10, 2022    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders