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 willing and able to sign a consent form, along with a study partner or legal representative if needed.
• People who are at least 18 years old.
• People who could become pregnant must have a negative pregnancy blood test at the start of the study, agree not to try to become pregnant during the study and for a set period after the last dose of study drug, agree not to breastfeed during that same period, and agree to use highly effective contraception if their partner has not been sterilised.
• People who carry a gene mutation in the APP, PSEN1, or PSEN2 gene linked to a condition called Dominantly Inherited Alzheimer's Disease (DIAD), or people who do not know their own mutation status but have a close family member with one of these mutations, putting them at direct risk of inheriting it.
• People who are estimated to be between 11 and 25 years before the age at which memory or thinking 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 approved and validated.
• People who have good enough vision and hearing to complete all thinking and memory assessments in the trial.
• People who have been on a stable dose of any ongoing medications for at least 30 days before the baseline visit (medications taken only occasionally, such as for migraines, antibiotics, or short-term stomach or cold medicines, are not included in this requirement).
• People who have a study partner — such as a family member or close friend — who can reliably report on the participant's day-to-day thinking and functioning, is willing to attend study visits, and agrees to sign the required consent form if needed.
• People who agree not to donate blood or blood products from the start of the study until a set period after the last dose of study drug.
• People who, in the opinion of the trial doctor, are likely to follow the study requirements and complete the full trial.
• People who are able and willing to complete all study-related tests, visits, and procedures.

Who may not be able to join:

• People who have a significant brain or psychiatric condition (other than Alzheimer's disease) that currently affects thinking or could do so during the study — such as serious head injury with lasting effects, epilepsy, certain movement or brain diseases, fluid on the brain, brain infections, brain tumours, or mental health conditions such as schizophrenia, bipolar disorder, or severe depression. Conditions that are well controlled with medication, or past conditions that are unlikely to affect thinking, may not be disqualifying (confirm with trial site).
• People considered to be at high risk of suicide, including those with significant suicidal thoughts or a suicide attempt in the past 12 months, or those identified as higher risk on a standard screening tool. Currently stable mild depression or use of antidepressant medication is not disqualifying.
• People with a history of a clinically evident stroke, or significant narrowing or disease in the blood vessels supplying the brain, or other major risk factors for stroke or brain bleeding — such as a type of irregular heartbeat called atrial fibrillation combined with blood thinners, or a mini-stroke in the past 12 months — that may affect thinking or the ability to complete the study. Low-dose aspirin (325 mg or less per day) is not disqualifying.
• People whose alcohol or substance use currently meets, or has met within the past year, the clinical definition of a use disorder.
• People whose brain MRI scan at the start of or before the study shows significant abnormalities, definite small bleeds, bruising of brain tissue, or aneurysms. Minor or clinically insignificant findings may not be disqualifying (confirm with trial site).
• People who have certain implanted medical devices — such as some pacemakers, aneurysm clips, artificial heart valves, certain ear implants, or metal objects in the eyes, skin, or body — that would make having an MRI scan unsafe.
• People with serious heart or blood pressure problems — such as uncontrolled high blood pressure, a history of heart attack, heart failure, atrial fibrillation, or a specific abnormality on a heart tracing (ECG) — that the trial doctor believes would interfere with participation or study results.
• People with liver or kidney problems that, in the trial doctor's opinion, would interfere with participation or study results.
• People with a history of HIV infection, a Hepatitis B infection within the past year, an inadequately treated Hepatitis C infection, or a bacterial infection affecting the nervous system such as syphilis or Lyme disease.
• People with a history of severe allergic reactions to multiple or several drugs, significant allergies, or severe skin reactions after treatment, or known sensitivity to certain imaging agents used in this trial — if the trial doctor considers this a high risk.
• People who have taken immune-suppressing medications (such as steroid tablets or injections) within the 90 days before the baseline visit, or cancer chemotherapy within the past 3 years. Steroid creams, nasal sprays, or inhalers for asthma are not disqualifying.
• People with a clinically significant thyroid condition that is not well managed, or a clinically significant vitamin B12 deficiency.
• People with unstable or poorly controlled diabetes that the trial doctor believes would interfere with the study. Re-screening after 3 months may be possible once diabetes is better controlled.
• People with severe obesity and related health complications, or where body size would prevent MRI scanning.
• People currently taking prescription blood-thinning medications such as warfarin, dabigatran, rivaroxaban, or apixaban. Low-dose aspirin (less than 325 mg per day) is not disqualifying.
• People who have received a type of antibody treatment targeting a protein associated with Alzheimer's disease within the past 6 months, or within 5 times the drug's clearance period, whichever is longer.
• People who have taken part in another experimental drug treatment within 3 months before screening, or within 5 times the drug's clearance period, whichever is longer.
• People who do not have adequate vein access for blood draws.
• People with clinically relevant abnormalities in blood counts, blood clotting, or blood chemistry results.
• People with a history of cancer that the trial doctor believes carries a high risk of coming back and affecting their ability to participate in the study.
• People with any other medical condition that is expected to worsen or change significantly in a way that could affect the reliability of the study results or put the person at particular risk.
• People who are currently enrolled in another clinical study — including non-drug studies — or have been within the past month before screening, unless prior approval has been given.
• People who carry a specific genetic variant known as the "Dutch" APP E693Q mutation.
• People who are unable to complete all required assessments at the baseline visit with results that meet the trial's eligibility standards.

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