Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease (NCT07553338) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease
United States20 participantsStarted 2026-04
Plain-language summary
The present study will administer the drug leronlimab to 20 participants who are above 50 years old with Alzheimer's disease (AD) or mild cognitive impairment due to AD. While leronlimab is considered safe in other diseases like Human Immunodeficiency Virus (HIV) and certain types of breast cancer, its safety and tolerability in AD will be tested for the first time. The main purpose of this study is to learn:
1. Is this drug safe for participants with AD and MCI due to AD?
2. Does leronlimab change levels of brain inflammation?
The results of this study could lead to future studies with more participants that will test whether leronlimab may slow or prevent the decline in thinking abilities and brain function in this group of participants. Using leronlimab for Alzheimer's disease is experimental, which means that the Food and Drug Administration (FDA) has not approved Leronlimab for this purpose.
Participants will be asked to take leronlimab once a week for 12 weeks in our clinic or in their own home. Participants will also be asked to complete the below procedures before and after taking leronlimab for 12 weeks:
1. Undergo 2 types of brain scans, Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
2. Visit our clinic for routine lab work, an electrocardiogram (ECG), and a physical exam.
3. Donate blood so the researchers can better understand how leronlimab affects levels of inflammation and proteins related AD in the blood.
4. Undergo a series of tests and questionnaires that test thinking abilities.
5. Have weekly phone calls with researchers to let them know if there are side effects will taking this drug.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. Adult males or females, 50 years of age and older
✓. Biomarker confirmed mild-to-moderate i.e., mild cognitive impairment/AD (MCI/AD) based on standard criteria (CDR 0.5 to 1.5).
✓. Cognition intact enough to participate in study procedures including cognitive testing (MoCA\>11)
✓. Clinically normal resting 12-lead ECG at screening or, if abnormal, considered not clinically significant by the investigator
✓. Participant (or legally authorized representative) provides written informed consent prior to initiation of any study procedures
✓. Understands and agrees to comply with planned study procedures
✓. If receiving an FDA approved drug that treat the symptoms of AD (e.g., cholinesterase inhibitors and/or memantine) must be on a stable dose for at least 12 weeks prior to baseline
✓. If receiving an FDA approved drug that targets brain amyloid must be on a stable dose for at least 12 weeks prior to baseline
Exclusion criteria
What they're measuring
1
Mean change from baseline in whole-brain inflammation using 11C-DPA-713 Positron Emission Tomography (PET)
Timeframe: Baseline; Week 13
Trial details
NCT IDNCT07553338
SponsorWeill Medical College of Cornell University
. Participant with a gene variation that would inhibit binding to the PET radiotracer (11C-DPA-713) and/or clinical factors that could affect PET signal, such as chronic use of benzodiazepines or NSAIDS
✕. Women who are pregnant or breastfeeding at screening or baseline
✕. Females of childbearing potential who within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following: (1) total abstinence, if it is their preferred and usual lifestyle; (2) an intrauterine device or intrauterine hormone-releasing system; (3) a contraceptive implant; (4) an oral contraceptive (with additional barrier method) with the participant being on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation; (5) have a vasectomized partner with confirmed azoospermia. Women who do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation shall be excluded. However, at the discretion of the investigator it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject, then the subject must agree to use a medically acceptable method of contraception, i.e., double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide. NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
✕. Male participants with female partners of childbearing potential are not eligible to participate if they do not agree to ONE of the following from the time prior to first dosing until 90 days after the last dose of study treatment: (1) are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; (2) Agree to use a male condom plus partner use of a contraceptive method with a failure rate of \<1% per year when having penile-vaginal intercourse with a partner of childbearing potential who is not currently pregnant. Men with a pregnant or breastfeeding partner are not eligible to participate if they do not agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration from the time prior to first dosing until 90 days after the last dose of study treatment
✕. Participants who are HIV positive at screening
✕. Participants with a past history (suspected or confirmed) of Hepatitis B should have HBsAg testing at screening and are excluded if HBsAg is positive
✕. Participants with a past history (suspected or confirmed) of Hepatitis C should have HCV RNA PCR testing at screening and are excluded if the HCV RNA PCR test is positive
✕. Presence based on exam, history or MRI of significant brain disease other than AD such as schizophrenia, epilepsy, Parkinson's disease or large territory stroke