Start: December 28, 2021
End: September 29, 2023
What Is This Study About?
Lomecel-B is an experimental cell therapy designed to reduce inflammation and improve cognition in people with Alzheimer's disease. This Phase 2 study, called CLEARMIND, will evaluate the safety and effects of Lomecel-B on older adults with early-stage Alzheimer's. Participants will be assigned to receive one of three doses of the cell therapy or placebo by IV infusion at four treatment sessions over three months. All participants will visit the study clinic for cognitive assessments and brain imaging throughout the 41-week study. Researchers will monitor safety and tolerability of the study drug, as well as any changes in cognitive function.
Do I Qualify To Participate in This Study?
- Diagnosis of early-stage Alzheimer's disease, as indicated by:
- Mini-Mental State Examination score of 19 to 23
- Evidence of brain amyloid plaques, based on PET scan results
- Brain structure changes, based on MRI brain scan
- Body weight between 88 and 330 pounds
- Living in the community or in an assisted living facility
- Have an adult caregiver who:
- Lives with the participant or sees the participant for at least two hours per day, at least three days per week
- Will accompany the participant to each study visit
- Can read, understand, and speak English and/or Spanish
Must NOT have:
- Diagnosis of a significant neurodegenerative disease, other than Alzheimer's disease (e.g., frontotemporal dementia, dementia due to acquired immunodeficiency syndrome, Creutzfeldt-Jakob disease, Lewy body dementia, progressive supranuclear palsy, significant vascular damage in brain, normal pressure hydrocephalus)
- History of stroke or a seizure disorder
- Evidence of vascular damage in brain
- Cancer within past two years, with the exception of treated basal cell carcinoma, squamous cell carcinoma, precancerous melanoma, or cervical carcinoma
- Positive test for hepatitis B, hepatitis C, HIV, or syphilis
- Any condition that is projected to limit life expectancy to less than one year
- Any condition that could make undergoing the following study procedures unsafe:
- MRI brain scan (e.g., metal shrapnel; pacemaker; severe claustrophobia; presence of metal objects in the eyes, skin, or heart)
- PET scan using a radioactive tracer that binds to amyloid (e.g., pregnancy, sensitivity to materials being used, poor vein access, prior radiation exposure that, when combined with study PET scan, would exceed radiation limits)
- History of gastric bypass surgery
- Known hypersensitivity to dimethyl sulfoxide
- Significantly abnormal clinical or laboratory test results, including:
- Vitamin B12 or folate deficiency
- Abnormal thyroid stimulating hormone or free T4
- Resting blood oxygen saturation < 93%
- Blood pressure > 180/110
- Regular use (more than once a month) of any of the following medications:
- High doses of corticosteroids or other steroidal anti-inflammatory medication (e.g., prednisone) with the exception of steroidal nasal sprays, asthma inhalers, topical steroids, and hormone replacement therapy
- Anticytokine antibody or therapy (e.g., anti-TNF-)
- History of organ transplant or expect to receive transplant during trial, except for cornea, bone, skin, ligament, or tendon transplants
- Pregnant, nursing, or of childbearing potential while not practicing effective contraception
- Participation in another clinical trial for an experimental drug or device within one month prior to study screening or, in the opinion of the investigator, within the past five years
- Living in a nursing care residence or other long-term care facility
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Who Is the General Study Contact?
For more information, email ALZresearch@longeveron.com.
Kevin N Ramdas, MD, MPH
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Longeveron Inc.
Source: ClinicalTrials.gov ID: NCT05233774