Phase 3 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 who are at least 18 years old.
• People who carry a mutation in one of three genes (APP, PSEN1, or PSEN2) linked to a hereditary form of Alzheimer's disease, or people who do not yet know their own mutation status but have a known mutation in their family that puts them at direct risk of inheriting it.
• People who are estimated to be between 11 and 25 years before the age at which cognitive symptoms would be expected to begin, based on their mutation type or family history.
• People whose thinking and memory are currently normal, as measured by a standard assessment tool (CDR-SB score of 0).
• People who are fluent in a language for which the trial's thinking and memory tests have been properly translated and validated.
• People who have good enough vision and hearing to complete all of the thinking and memory tests in the trial.
• People who have been on stable doses of any ongoing medications for at least 30 days before the start of the trial (except medicines taken only occasionally, such as for migraines, antibiotics, or stomach bugs).
• People who have a "study partner" — someone who knows them well, can accurately report on their thinking and everyday abilities, and is willing to attend relevant visits and sign the required forms.
• People who are willing and able to complete all trial visits, tests, and procedures.
• People who agree not to donate blood or blood products for the duration of the trial and for a set period after the last dose of study medication.
• People of childbearing potential who have a negative pregnancy test at the screening visit, and who agree not to try to become pregnant, not to breastfeed, and to use highly effective contraception for the duration of the trial and for a set period after the last dose of study medication (if their partner has not been sterilised).
• People who are willing to provide written, signed, and dated consent to participate, in line with local regulations.

Who may not be able to join:

• People who have a significant neurological condition (other than Alzheimer's disease) or a psychiatric condition — such as schizophrenia, bipolar disorder, or major depression — that could affect thinking or the ability to complete the trial. Conditions that are well controlled with medication or that are unlikely to affect thinking may not be disqualifying (confirm with trial site).
• People who are considered at high risk of suicide, including those with significant suicidal thoughts or a suicide attempt in the past 12 months, or those identified as high risk on a standard screening scale. Stable mild depression or current use of antidepressant medication is not disqualifying.
• People with a history of stroke, or significant narrowing or build-up in the arteries supplying the brain, or other major risk factors for stroke or brain bleeding — including atrial fibrillation requiring blood thinners, or a mini-stroke (TIA) in the past 12 months — that may affect thinking or the ability to complete the trial. Low-dose aspirin (up to 325 mg daily) is not disqualifying.
• People with a current or recent (within the past year) alcohol or substance use problem that meets standard clinical diagnostic criteria.
• People whose brain MRI scan (either historical or taken at the baseline visit) shows significant abnormalities, definite small bleeds, brain contusion, tissue damage from prior injury, or aneurysms. Minor or clinically insignificant findings are not disqualifying.
• People who have certain implanted medical devices — such as some pacemakers, aneurysm clips, artificial heart valves, ear implants, or metal objects in the body — that would make it unsafe to have an MRI scan.
• People with significant heart or cardiovascular problems, such as uncontrolled high blood pressure, history of heart attack, heart failure, atrial fibrillation, or a prolonged QT interval on a heart tracing (ECG), that the investigator believes would interfere with the trial.
• People with significant liver or kidney problems that the investigator believes would interfere with the trial.
• People with a history of HIV infection, Hepatitis B infection in the past year, inadequately treated Hepatitis C, or certain nervous system infections (such as syphilis or Lyme disease affecting the brain) that carry a high risk of interfering with the trial.
• People with a history of severe allergic reactions to multiple drugs, severe skin hypersensitivity reactions, or sensitivity to the specific imaging agents used in the trial, where this carries a high risk of interfering with participation.
• People who have taken immunosuppressive medications (such as systemic steroids) within the 90 days before the baseline visit, or chemotherapy for cancer within the past 3 years. Topical, nasal, or inhaled steroids are not disqualifying.
• People with a significant untreated or poorly controlled thyroid condition, or a clinically significant vitamin B12 deficiency.
• People with unstable or poorly controlled diabetes that the investigator believes would interfere with the trial. Re-screening may be possible after 3 months if diabetes control improves.
• People with severe obesity that causes significant health complications or that would prevent MRI scanning.
• People currently taking blood-thinning medications such as warfarin, dabigatran, rivaroxaban, or apixaban. Low-dose aspirin (under 325 mg daily) is not disqualifying.
• People who have received a monoclonal antibody treatment targeting amyloid-beta (a protein involved in Alzheimer's disease) within the past 6 months or 5 half-lives of that drug before screening, whichever is longer.
• People who have received any other investigational (experimental) drug treatment within 3 months before screening, or within 5 half-lives of that drug, whichever is longer.
• People who do not have suitable veins for blood draws.
• People with clinically significant abnormalities in blood counts, clotting, or blood chemistry results.
• People with a history of cancer that the investigator believes has a high risk of coming back and affecting participation in the trial.
• People with any other medical condition that is expected to worsen or change significantly in a way that could affect assessments or put the person at particular risk.
• People who are currently participating, or who have participated in the past month, in another clinical or non-drug study, without prior approval from the trial team.
• People who carry the specific genetic variant known as the "Dutch" APP E693Q mutation.
• People whose baseline visit results do not meet the required thinking and memory score thresholds for eligibility.
• People whose screening MRI (reviewed centrally) shows certain brain imaging abnormalities, including fluid around brain tissue (ARIA-E), more than 4 small brain bleeds, any superficial iron deposits, any large brain bleed, or severe white matter disease.
• People who have received lecanemab, donanemab, or other investigational amyloid-lowering treatments within the past 6 months or 5 half-lives before screening, whichever is longer.
• People who work directly at the trial site on this study, or who are an immediate family member (spouse, parent, child, or sibling) of someone who does.
• Employees of the sponsoring company (Lilly) or of third-party organisations involved in this study that require exclusion of their staff, or people whose study partner is such an employee.

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