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Tests treatment safety and results for Mild Cognitive Impairment (MCI) Due to Alzheimer's...
Official title Safety Assessment of Leronlimab and Its Effect on Brain Inflammation in Alzheimer's Disease
ClinicalTrials.gov ID: NCT07553338
What this study is testing
What is Leronlimab (700mg)?
Leronlimab (700mg) is an investigational medicine, given as an once-weekly, being studied as a potential treatment for mild cognitive impairment (mci) due to alzheimer's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Male participants with female partners of childbearing potential are not eligible to participate if they do not agree to ONE of the following from...
- Participants who are HIV positive at screening
See the full eligibility criteria
Who can 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
- 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.
What rules you out
- 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...
- 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...
- 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
- 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...
- 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...
- 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...
- Participants who are participating in other treatment 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.