No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 – 120
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Other
Participants needed
200 (estimated)
Sponsor
National Institute on Aging (NIA) · NIH
Who this trial is looking for
This trial is looking for older adults aged 65 and over who have mild cognitive impairment or early-stage Alzheimer's disease, as well as healthy older adults. Participants will engage in brain training exercises and may take psilocybin, a compound found in certain mushrooms, to see how it can improve brain function.
Are You a Good Fit for This Trial?
Rules you outSevere mood disordersEpilepsyOther dementias
You may be able to join if
I am at least 65 years old
I can provide informed consent
I have early-stage Alzheimer's disease or mild cognitive impairment
I have no serious neuropsychiatric symptoms
I can take oral medication
I have a study partner to support me
I am willing to comply with all study procedures
You may not be able to join if
I have had a stroke or transient ischemic attack in the past year
I have a serious mental health condition like severe depression or PTSD
I have a history of epilepsy or other serious neurological disorders
I have had suicidal thoughts or behavior in the last 6 months
I have had a traumatic brain injury
I do not have a supportive study partner if I have early-stage Alzheimer's
I am pregnant or not using effective birth control
I have other types of dementia
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Background:
Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults. They also want to know if psilocybin, a compound found in certain mushrooms, can further support improved brain function.
Objective:…
Background:
Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults. They also want to know if psilocybin, a compound found in certain mushrooms, can further support improved brain function.
Objective:
To learn how regular cognitive training, with or without psilocybin, can improve brain health in older adults.
Eligibility:
People aged 65 years and older with mild cognitive impairment or early-stage Alzheimer s disease. Healthy older adults with normal cognition are also needed.
Design:
Participants will be screened. They will have a test of their heart function and an imaging scan. They will have mental health screening and tests of their thinking and memory. They will practice brain-training tasks on a tablet.
Participants will be divided into 2 groups: 1 will have cognitive training plus psilocybin; 1 will have cognitive training only.
Those having cognitive training only will have 5 or 6 clinic visits. They will take the tablet home to practice brain training daily. They will wear a device to measure brain waves as they sleep; they may have 1 overnight stay in the clinic, or they may wear the device at home. Imaging scans and other tests will be repeated at each visit.
Those taking psilocybin will have up to 9 clinic visits. In addition to the visits for cognitive training, they will take 1 psilocybin capsule by mouth 2 weeks apart (the second dose is optional). They will remain in the clinic for 24 hours after each dose.
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