Phase 1 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:

• You are able to give your own signed consent to take part in the study.
• You are between 21 and 80 years old (inclusive).
• You have been diagnosed with mild or moderate Alzheimer's disease, based on a specific assessment scale (called the Clinical Dementia Rating, scored 0.5 to 2), and the doctor believes you could complete the study.
• You have test results from spinal fluid, a brain scan (PET), or a blood test that support your Alzheimer's diagnosis, or you carry a specific confirmed genetic change linked to Alzheimer's disease (confirm with trial site).
• You are fluent in English.
• You have a reliable family member, friend, or caregiver who can support your participation in the study.
• You are able to have spinal fluid samples taken (lumbar puncture), MRI scans, and blood draws.
• You are willing to allow your biological samples and personal data to be shared with Novartis, the commercial partner involved in this research.

Who may not be able to join:

• You currently live in a skilled nursing facility or a dedicated dementia care facility.
• You have a significant abnormal result on a laboratory (blood or urine) test (confirm with trial site).
• You have attempted suicide or had a specific plan for suicide that required a hospital stay within the past 12 months.
• You have taken part in a trial of an experimental treatment within approximately the last 6 months (or longer, depending on the treatment).
• You have ever received a specific type of experimental gene-based therapy targeting Alzheimer's disease, including a type called antisense oligonucleotides (ASOs) (confirm with trial site).
• You have previously had an allergic reaction to the study drug or similar types of medicines.
• You have a condition that raises your risk of a brain or spinal cord infection (meningitis), unless you are already receiving appropriate preventive treatment.
• You have another medical condition or brain/neurological condition (not related to Alzheimer's) that could affect your thinking or memory test results.
• The study doctor believes another health condition or circumstance makes it unsuitable or unsafe for you to participate.
• The study doctor believes you are unlikely to be able to cooperate with, attend, or follow the study requirements.
• You currently drink more than 14 units of alcohol per week, currently use cannabis, or have had a problem with alcohol or drug misuse (other than nicotine) in the past 2 years.
• You are currently taking certain medications, including immunosuppressants, antipsychotics, lithium, or certain other drugs that could affect the brain — specific medicines are allowed but only if the dose has been stable for at least 12 weeks before joining and stays stable throughout the study (confirm with trial site).
• You are unable to have an MRI scan, for example due to severe claustrophobia, or because you have a pacemaker, defibrillator, or certain metal implants or fragments in your body.
• You have significant signs of major damage to the blood vessels in your brain.
• You are a male who is sexually active and unwilling to use a condom from the time of consent until at least 15 weeks after receiving the treatment.
• You are pregnant, breastfeeding, or are a woman who could become pregnant and are not willing or able to use highly effective contraception as specified by the study (confirm with trial site).
• You regularly take blood-thinning medications (anticoagulants or anti-platelets) in a way that would make a lumbar puncture unsafe.
• You have tested positive for HIV, Hepatitis B, or Hepatitis C.

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