Status:
COMPLETED
Lomecel-B Effects on Alzheimer's Disease
Lead Sponsor:
Longeveron Inc.
Collaborating Sponsors:
bioRASI, LLC
Conditions:
Mild Alzheimer's Disease
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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.
- Provides written informed consent to participate on the trial (reporting on patient observations).
- Either lives with the patient, or sees the patient for at least 2 hours/day for at least 3 days/week.
- Is willing and able to participate in the study, and agrees to accompany the patient to each study visit.
- 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
- 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.
Key Trial Info
Start Date :
December 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05233774
Start Date
December 28 2021
End Date
September 29 2023
Last Update
February 20 2024
Active Locations (13)
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1
Visionary Investigators Network
Aventura, Florida, United States, 33180
2
Brain Matters Research
Delray Beach, Florida, United States, 33445
3
Science Connections - Research Partner Group Multispecialty Group
Doral, Florida, United States, 33178
4
Bruce W. Carter VA Medical Center
Miami, Florida, United States, 33125