Mild Cognitive Impairment (MCI) Due to Alzheimer's DiseasePhase 2SALIENT-ADNCT07553338
Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease
A Phase 2 study testing Leronlimab (700mg) in people with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease and Alzheimer's Disease, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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 (MCI) due to AD. While leronlimab is considered safe in other diseases like Human Immunodeficiency Virus (HIV) and certain types of cancer, its safety and… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, Alzheimer's Disease
- What is being tested?
- Leronlimab (700mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential participants are required to meet all the following criteria for enrollment into the study:
- 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
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- 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
- If the participant is taking any supplement or medical food that may affect brain function must be on a stable dose or regimen for at least 12 weeks prior to baseline
- Participants on permitted concomitant medications should be on a stable dose of the permitted concomitant medication for at least 4 weeks unless a shorter duration is deemed acceptable by the investigator
- In the opinion of the investigator, have adequate cognition, literacy, vision, and hearing for neuropsychological testing
- The participant should have a study partner who can support the study participant and provide collateral information.
Who cannot join
- Potential participants meeting any of the following criteria will be excluded from enrolment into the study:
- 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
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- 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
- Current substance abuse in accord with Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria
- Significantly depressed (Geriatric Depression Scale > 10)
- Contraindications to MRI scanning, including claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in skull and cardiac devices other than those approved as safe for use in MRI scanners)
- Contraindications to PET
- Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG at screening or baseline which in the opinion of the investigator require further investigation or treatment or which may interfere with study procedures or safety
- Any other medical conditions (e.g., cardiac, respiratory, gastrointestinal, or renal) which are not stable and/or adequately controlled, or which in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
- Participants with malignant neoplasms within 3 years of screening (except for basal or squamous cell carcinoma in situ of the skin or localized prostate cancer in male participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before screening need not be excluded
- Participants who are participating in other interventional clinical trials that in the opinion of the investigator is likely to interfere with participation in or completion of the study or to affect study results or interpretation.
- Participants who were dosed in a clinical trial involving any new investigational drug for AD within 12 months prior to screening unless it can be documented that they received placebo
- Participants are not eligible if they have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab
- Participants who have previously received leronlimab
- Participants who are taking prohibited medications
- Inability for patient or proxy to provide informed consent or to comply with test requirements
- Visual or hearing impairment that, in the opinion of the investigator, would prevent the participant from performing psychometric tests accurately
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine Brain Health Imaging Institute
New York, New York, 10065
Edward Spector, BS, 6469628506, ejs4002@med.cornell.edu
About this study
Official title: Safety Assessment of Leronlimab and Its Effect on Neuroinflammation Targets in Alzheimer's Disease
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 (MCI) due to AD. While leronlimab is considered safe in other diseases like Human Immunodeficiency Virus (HIV) and certain types of cancer, its safety and tolerability in AD will be tested for the first time. The main purpose of this study is to learn:
- Is this drug safe for participants with AD and MCI due to AD?
- Does leronlimab change levels of brain inflammation?
Read more
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:
- Undergo 2 types of brain scans, Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
- Visit our clinic for routine lab work, an electrocardiogram (ECG), and a physical exam.
- Donate blood so the researchers can better understand how leronlimab affects levels of inflammation and proteins related to AD in the blood.
- Undergo a series of tests and questionnaires that test thinking abilities.
- Have weekly phone calls with researchers to let them know if there are side effects while taking this drug.
- Being tested
- Leronlimab (700mg)
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Clinical Trial
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leronlimab (700mg)Drug
Leronlimab, also known as PRO 140, is a humanized IgG4κ monoclonal antibody to Chemokine Receptor type 5 (CCR5). It is currently in development to potentially treat a number of different diseases, including but not limited to, metastatic colorectal cancer (mCRC), triple-negative breast cancer (TNBC), and other oncological conditions.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | All participants (N = 20) enrolled into this phase 2a, single-arm study will receive 12 doses of leronlimab. Receives: Drug: Leronlimab (700mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in whole-brain inflammation using 11C-DPA-713 Positron Emission Tomography (PET)
The primary outcome measure is leronlimab's effect on brain inflammation using a PET tracer that measures translocator protein (TSPO) activation on microglia.
Measured: Baseline; Week 13
Secondary outcomes (2)
Number and severity of treatment-emergent adverse events (TEAEs)
Measured: Baseline through Week 17
Number of serious adverse events (SAEs)
Measured: Baseline through Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start30 Apr 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI) Due to Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The present study is a Phase 2a, single arm, open label, proof of principle study to evaluate the PET-measured effect on brain inflammation and safety of leronlimab in people with biomarker confirmed mild-to-moderate i.e., mild cognitive impairment/AD
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- William H. Donner Foundation
- Responsible party
- Sponsor
- Investigators
- Tracy A Butler, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553338
- Sponsor's protocol ID
- 24-09027933
- Acronym
- SALIENT-AD
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of Leronlimab and Its Effect on Neuroinflammation Targets in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07553338
- Acronym / sponsor ID
- SALIENT-AD / 24-09027933
- Keywords
- Alzheimer's Disease, Mild Cognitive Impairment, Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- William H. Donner Foundation
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (MCI) due to AD. While leronlimab is considered safe in other diseases like Human Immunodeficiency Virus (HIV) and certain types of cancer, its safety and tolerability in AD will be tested for the first time. The main purpose of this study is to learn:
- Is this drug safe for participants with AD and MCI due to AD?
- 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:
- Undergo 2 types of brain scans, Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
- Visit our clinic for routine lab work, an electrocardiogram (ECG), and a physical exam.
- Donate blood so the researchers can better understand how leronlimab affects levels of inflammation and proteins related to AD in the blood.
- Undergo a series of tests and questionnaires that test thinking abilities.
- Have weekly phone calls with researchers to let them know if there are side effects while taking this drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The present study is a Phase 2a, single arm, open label, proof of principle study to evaluate the PET-measured effect on brain inflammation and safety of leronlimab in people with biomarker confirmed mild-to-moderate i.e., mild cognitive impairment/AD
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: Leronlimab (700mg)All participants (N = 20) enrolled into this phase 2a, single-arm study will receive 12 doses of leronlimab. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Potential participants are required to meet all the following criteria for enrollment into the study:
- 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
Key exclusion criteria (23 listed)
- Potential participants meeting any of the following criteria will be excluded from enrolment into the study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leronlimab (700mg)Leronlimab, also known as PRO 140, is a humanized IgG4κ monoclonal antibody to Chemokine Receptor type 5 (CCR5). It is currently in development to potentially treat a number of different diseases, including but not limited to, metastatic colorectal cancer (mCRC), triple-negative breast cancer (TNBC), and other oncological conditions. | Drug | Single arm |
Primary outcome
Mean change from baseline in whole-brain inflammation using 11C-DPA-713 Positron Emission Tomography (PET)
Time frame: Baseline; Week 13
The primary outcome measure is leronlimab's effect on brain inflammation using a PET tracer that measures translocator protein (TSPO) activation on microglia.
2 secondary outcomes
Number and severity of treatment-emergent adverse events (TEAEs)
Time frame: Baseline through Week 17
Number of serious adverse events (SAEs)
Time frame: Baseline through Week 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tracy A Butler, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leronlimab (700mg) in people with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease and Alzheimer's Disease, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward Spector, BS (6469628506, ejs4002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in whole-brain inflammation using 11C-DPA-713 Positron Emission Tomography (PET) (time frame: Baseline; Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.