Phase 2 Alzheimer's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 50 or older, of any gender
• People who have had biomarker testing confirming mild cognitive impairment or mild-to-moderate Alzheimer's disease, with a CDR score between 0.5 and 1.5 (confirm with trial site)
• People whose thinking and memory are still at a level that allows them to take part in cognitive tests, based on a specific memory screening score (MoCA above 11)
• People whose heart tracing (ECG) at screening is normal, or if it shows something unusual, the trial doctor considers it not medically significant
• People (or their legal representative) who are willing and able to give written consent before any study procedures begin
• People who understand and agree to follow all planned study procedures
• People already taking an FDA-approved medication for Alzheimer's symptoms (such as certain memory drugs) who have been on a stable dose for at least 12 weeks before the study starts
• People already taking an FDA-approved medication that targets brain amyloid who have been on a stable dose for at least 12 weeks before the study starts
• People taking any supplement or medical food that may affect brain function who have been on a stable dose or routine for at least 12 weeks before the study starts
• People taking other allowed medications who have been on a stable dose for at least 4 weeks, unless the trial doctor decides a shorter time is acceptable
• People who, in the trial doctor's opinion, have enough cognitive ability, literacy, vision, and hearing to complete memory and thinking tests
• People who have a study partner (such as a family member or carer) who can support them and provide background information about them

Who may not be able to join:

• People who have a specific genetic variation that could interfere with a type of brain scan used in the trial (PET scan with a tracer called 11C-DPA-713), or who regularly use certain medications (such as benzodiazepines or anti-inflammatory drugs like NSAIDs) that could affect the scan results
• People who are pregnant or breastfeeding at the time of screening or at the start of the study
• Women who could become pregnant and have not been using a highly effective form of contraception for at least 28 days before joining the study — acceptable methods include total abstinence (as a usual lifestyle), an IUD or hormonal IUD, a contraceptive implant, an oral contraceptive used with a barrier method (on a stable dose for at least 28 days), or a vasectomised partner with confirmed absence of sperm. If none of these are suitable, the trial doctor may allow double-barrier methods (such as a condom plus diaphragm with spermicide). This requirement also applies for 28 days after finishing the study drug. Women are considered able to become pregnant unless they have been through menopause (no periods for at least 12 consecutive months) or have had surgical sterilisation (such as removal of the ovaries, fallopian tubes, or uterus, at least one month before the study starts)
• Male participants with female partners who could become pregnant, unless they agree to either abstain from intercourse or use a male condom plus a partner contraceptive method with less than 1% failure rate per year — from before the first dose until 90 days after the last dose. Men whose partner is pregnant or breastfeeding must agree to abstain or use a condom throughout that same period
• People who test positive for HIV at screening
• People with a past history (suspected or confirmed) of Hepatitis B who test positive for the HBsAg marker at screening
• People with a past history (suspected or confirmed) of Hepatitis C who test positive on an HCV RNA test at screening
• People who have, based on their medical history, examination, or brain scan (MRI), a significant brain condition other than Alzheimer's disease — such as schizophrenia, epilepsy, Parkinson's disease, or a large stroke
• People who currently have a substance use disorder, as defined by standard psychiatric guidelines (DSM-5)
• People with significant depression, based on a standard depression questionnaire score above 10
• People who are unable to have an MRI scan — for example, due to claustrophobia, having a pacemaker or defibrillator, or having certain metal implants in the body
• People who have a medical reason that prevents them from having a PET scan (confirm with trial site)
• People who have other significant abnormalities found during physical examination, vital sign checks, blood tests, or ECG at screening, which in the trial doctor's opinion need further investigation or could affect safety or study results
• People who have other medical conditions (such as heart, lung, digestive, or kidney conditions) that are not stable or well-managed, or that the trial doctor believes could affect safety or interfere with the study
• People who have had a cancer diagnosis within the past 3 years — except for certain skin cancers or localised prostate cancer. People who have been in confirmed, uninterrupted remission for at least 3 years before screening may still be considered eligible (confirm with trial site)
• People who are currently in another interventional clinical trial that the trial doctor believes could interfere with this study or affect its results
• People who received an investigational (experimental) drug for Alzheimer's disease in a clinical trial within the 12 months before screening — unless it can be documented that they received a placebo (inactive treatment) in that trial
• People who have previously had an allergic reaction to a drug that is chemically or biologically similar to leronlimab (the study drug)
• People who have previously received leronlimab
• People who are taking medications that are not permitted in this trial
• People who are unable — either themselves or through a legal representative — to give informed consent or follow the study's test requirements
• People whose vision or hearing difficulties would, in the trial doctor's opinion, prevent them from accurately completing cognitive and memory tests

Important: Always verify eligibility with the trial site directly before applying.