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 between 50 and 85 years old (inclusive) at the time you sign the consent form
• You have below-average well-being, as measured by a standard questionnaire called the WHO-5 Well-Being Index
• You do not have significant memory or thinking problems, based on a standard mental assessment test score above 24
• You have someone in your life (such as a family member or friend) who sees or speaks with you at least once a week, is willing to provide information about how you are doing day-to-day, and can drive or accompany you home after the main study visit
• If you were assigned female at birth, you are not breastfeeding and have gone through menopause (no period for more than 12 months) or are otherwise physically unable to become pregnant
• If you were assigned male at birth, you agree not to donate sperm for 3 months after the main study visit, and if you could cause a pregnancy through sexual activity, you agree to use a condom plus ensure your partner uses a second reliable form of contraception for 3 months after the main study visit
• You are fluent in English
• You are able to understand what the study involves and can give your informed consent
• You are willing and available to follow all study procedures for the full duration of the study
• You are able to swallow capsules

Who may not be able to join:

• You have had a known allergic or serious reaction to psilocybin, dextromethorphan, or any inactive ingredients in the study capsules
• You are unable to reliably report on your own symptoms in a way that would allow valid study assessments
• You have any condition or feature that the study doctors believe could interfere with your participation or make it harder to interpret the study results (confirm with trial site)
• You have any implanted metal object or electronic device in your body that could make an MRI scan unsafe or interfere with it — examples include pacemakers, cochlear implants, certain joint replacements, vascular stents, or similar devices (confirm with trial site for the full list)
• You have a history of a metal injury to your eyes or body, or have tattoos with metallic ink, permanent makeup, or body piercings that cannot be removed
• You have any condition that could make an MRI scan unsafe or difficult, such as severe claustrophobia, certain movement disorders, or breathing problems
• You have a history of a condition called hallucinogen persisting perception disorder (HPPD), as defined by standard psychiatric guidelines
• You have a significant heart or cardiovascular condition, such as a serious irregular heartbeat, a mini-stroke in the last 6 months, a history of bleeding stroke, or a heart attack within the past year
• Your resting heart rate is below 60 or above 90 beats per minute at screening or before dosing
• You have high blood pressure (confirmed by repeated measurements)
• You have an abnormal heart rhythm measurement on an ECG (a test that checks heart electrical activity) above a certain threshold
• You have a significant uncontrolled heart rhythm problem, such as uncontrolled atrial fibrillation
• You experience palpitations, chest pain, or fainting during physical activity
• You have a major ongoing health condition such as epilepsy/seizures, insulin-dependent diabetes, advanced cancer or recent cancer treatment (within the last 12 months), or have had major surgery in the last 6 months or plan to have surgery during the study
• Your liver is not functioning well enough, based on blood test results (confirm with trial site) — note: people with a condition called Gilbert syndrome are allowed to join
• Your kidneys are not functioning well enough, based on a standard blood test measurement
• You are considered to be at an increased risk of falling

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