Is NCT07553338 recruiting in New York, NY?

Yes, NCT07553338 is currently recruiting participants at its New York, NY location. This mild cognitive impairment (mci) due to alzheimer's disease clinical trial is actively enrolling qualified participants.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease Clinical Trial in New York, NY

Q: How do I join the mild cognitive impairment (mci) due to alzheimer's disease clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease Study in New York

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: 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 to 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 while taking this drug.

Sponsor: Weill Medical College of Cornell University

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07553338) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease Treatment Options in New York, NY

If you're searching for mild cognitive impairment (mci) due to alzheimer's disease treatment options in New York, NY, this clinical trial (NCT07553338) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mild cognitive impairment (mci) due to alzheimer's disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mild cognitive impairment (mci) due to alzheimer's disease clinical trials near you to find additional studies recruiting in your area.

Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease Clinical Trial in New York, NY

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