Printed from Voxsanity (voxsanity.com.au) — NCT07721467 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Alzheimer's Disease Trial, Not Yet Recruiting
NCT07721467
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People aged 65 years or older.
- People who are able to understand and agree to take part in the study on their own behalf.
- People who are willing to follow all study procedures and are available for the full duration of the study.
- People who fall into one of two groups: those with early-stage Alzheimer's disease (mild memory problems meeting specific diagnostic criteria, with a CDR score of 0.5–1 and a MoCA memory test score of 20–25.5), or those with no memory or thinking problems (CDR score of 0 and MoCA score of 26 or above).
- For people in the early-stage Alzheimer's group: results from a specific FDA-cleared blood test (Lumipulse G p217-Tau/Abeta42 ratio) at or above a set level, OR previous amyloid PET scan or spinal fluid test results consistent with Alzheimer's disease (confirm with trial site for details).
- People who do not have serious behavioural or psychiatric symptoms such as delusions, hallucinations, or significant anxiety, aggression, irritability, or loss of inhibition, based on a specific questionnaire (NPI-Q).
- People currently taking Alzheimer's medications (acetylcholinesterase inhibitors and/or memantine) whose dose has been stable for at least 6 weeks before screening and is expected to stay stable during the main study period.
- People taking a single antidepressant (one SSRI — but not fluoxetine — or one SNRI, TCA, or MAOI), provided they are willing and able to gradually reduce and stop that medication after the first visit, with a washout period of at least 7 days before the second visit and at least 14 days before the psilocybin session or relevant study visit (confirm with trial site for details on tapering process).
- People taking bupropion at a dose of 300 mg/day or less, where the dose has been stable for at least 6 weeks before screening (no tapering required).
- People with no active thoughts of suicide with a plan or intent, and no suicidal behaviour in the past 6 months; people with low-level passive thoughts about death may be considered if a doctor judges the risk to be low and a safety plan is in place.
- For people in the early-stage Alzheimer's group: a study partner (such as a family member or close friend) who is willing to attend visits, provide background medical information, and offer support after psilocybin sessions is required; for people in the cognitively normal group, a study partner is encouraged but not required.
- People who are able to swallow oral medication.
- People who can become pregnant must have a negative pregnancy test at screening and before each psilocybin session, and must agree to use highly effective contraception starting at least 14 days before any psilocybin dose and continuing for 30 days after the last dose.
- Male participants whose partners could become pregnant must agree to use condoms and ensure their partner uses highly effective contraception during the same period, and must not donate sperm during the study or for 30 days after the last psilocybin dose.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People with significant brain or neurological conditions other than Alzheimer's disease, including stroke (except a single small, symptom-free old stroke), a mini-stroke (TIA) within the past year, extensive small vessel disease or brain microbleeds, multiple sclerosis, Parkinson's disease or related movement disorders, brain tumours, history of meningitis or encephalitis, moderate or severe traumatic brain injury, other types of dementia, or epilepsy (mild stable conditions such as migraines or essential tremor may be considered at the doctor's discretion).
- People with a current or past moderate-to-severe mood disorder such as treatment-resistant depression or bipolar disorder.
- People with a history of psychotic disorders (such as schizophrenia or schizoaffective disorder), unless the episode was a long time ago, brief, and clearly caused by medication misuse or overdose.
- People with active thoughts of suicide with any plan or intent in the past month, any suicidal behaviour in the past 6 months, or where a doctor judges there to be a currently elevated risk based on interview and assessment.
- People with severe PTSD, defined as a score of 4 or more on a specific screening tool (PC-PTSD-5) for men, or 3 or more for women.
- People with moderate to severe anxiety or personality disorders, as determined by the responsible doctor.
- People with mild depression or anxiety who are taking more than one antidepressant at the same time (combinations of SSRIs, SNRIs, MAOIs, TCAs, and/or bupropion) are not eligible; those on a single eligible antidepressant may be considered only if they are willing and able to taper and stop it under medical supervision, with all treating doctors in agreement and no elevated psychiatric risk (confirm with trial site for full details).
- People with any history of coronary artery disease.
- People with clinically significant heart rhythm or electrical abnormalities on an ECG, such as atrial fibrillation, a QTc interval above 450 ms, evidence of a past heart attack, or significant conduction problems, as determined by the responsible doctor.
- People with uncontrolled high blood pressure (systolic above 150 mmHg or diastolic above 95 mmHg), confirmed by repeated measurements after rest.
- People with a resting heart rate of 55 beats per minute or lower, or above 100 beats per minute, or a clinically significant irregular heartbeat.
- People with significant heart muscle disease (such as hypertrophic, dilated, or restrictive cardiomyopathy) or heart failure.
- People with moderate to severe heart valve disease or high blood pressure in the lungs (pulmonary hypertension).
- People with insulin-dependent diabetes.
- People with reduced kidney function (eGFR below 60 ml/min/1.73 m²).
- People with liver enzyme levels more than twice the upper limit of normal.
- People who test positive for HIV, hepatitis B, or hepatitis C.
- People with anaemia (haemoglobin below 12 g/dL in men, or below 11 g/dL in women).
- People with poor vein access (which may make blood draws difficult).
- People currently taking typical or atypical antipsychotic medications.
- People taking fluoxetine (a specific antidepressant), due to its long time to clear from the body; re-screening may be possible at a later date after fluoxetine has been stopped by the person's own doctor for at least 4 weeks (the trial team will not direct fluoxetine tapering).
- People taking multiple antidepressants at the same time (combinations of SSRIs, SNRIs, MAOIs, TCAs, and/or bupropion).
- People who regularly take benzodiazepines or non-benzodiazepine sleep medications (such as zolpidem or eszopiclone) and are unable or unwilling to gradually taper off and remain off them for at least 14 days before the relevant study visit; those who only take these occasionally as needed may be considered if they can avoid them for at least 72 hours before each psilocybin session and during overnight EEG recordings (confirm with trial site).
- People taking sleep-inducing medications (such as trazodone) who are unable to stop them at least 14 days before the relevant study visit.
- People who take melatonin or similar over-the-counter sleep aids and are unable to stop them at least 72 hours before the relevant study visit.
- People taking mood stabilisers (such as lithium) or long-acting opioids who are unwilling or unable to taper off and stop them before the study (confirm with trial site for full details).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Principal Investigator: Dimitrios I Kapogiannis, M.D., National Institute on Aging (NIA)
Phone: (410) 350-3941
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
National Institute on Aging (NIA)
Registry
ClinicalTrials.gov
Start date
1 October 2026
Est. completion
31 December 2030
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Determine whether psilocybin enhances neuroplasticity (Neuroplasticity Composite Score (NPCS))
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.