Psilocybin + Cognitive Training for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether a combination of mental exercises and psilocybin (a compound from certain mushrooms) can enhance brain function in older adults. The goal is to determine if these treatments improve memory, attention, and thinking. Participants will engage in mental exercises either alone or with psilocybin capsules. Ideal candidates are individuals aged 65 and older with mild memory issues or in the early stages of Alzheimer's disease. Healthy older adults with normal brain function are also needed. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that psilocybin, a substance found in certain mushrooms, is generally safe for older adults, including those with mild memory problems and early-stage Alzheimer's disease. Early findings suggest that psilocybin could be a treatment option without major safety issues. Most reported side effects were mild and temporary, such as headaches or nausea, which are common with many oral medications.
In studies with healthy older adults, psilocybin did not harm cognitive abilities and even improved skills like switching between different ideas, both in the short and long term. The safety results showed no serious negative effects on memory or overall health.
Current research supports that psilocybin is relatively safe for older adults, whether they have normal memory or early memory decline. Participants in studies generally tolerated it well, which is encouraging for its use in medical settings.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of psilocybin and cognitive training for Alzheimer's disease because it offers a novel approach to treatment. Unlike current options that primarily focus on managing symptoms through medications like cholinesterase inhibitors and memantine, psilocybin targets the brain's serotonin receptors, potentially enhancing neuroplasticity and cognitive function. Additionally, the integration of cognitive training aims to bolster this effect by engaging and stimulating the brain. This innovative combination could offer a more holistic and effective way to support cognitive health in Alzheimer's patients.
What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?
This trial will compare cognitive training alone with cognitive training plus psilocybin in both early-stage Alzheimer's Disease (AD) and normal cognition populations. Research has shown that psilocybin might enhance brain flexibility, allowing for easier transitions between different thoughts. In one study, participants who took psilocybin demonstrated improved thinking and brain flexibility for at least four weeks afterward. This finding suggests that psilocybin could enhance thinking and memory in older adults. It has also been found to increase emotional understanding, potentially boosting overall mental health. However, some studies have noted that psilocybin might temporarily affect skills like attention and decision-making. Overall, psilocybin appears promising for brain health, but its effects can vary.16789
Who Is on the Research Team?
Dimitrios I Kapogiannis, M.D.
Principal Investigator
National Institute on Aging (NIA)
Are You a Good Fit for This Trial?
This trial is for people aged 65 and older who have mild memory or thinking problems (early Alzheimer's) or are healthy with normal cognition. Participants must be able to take oral medication, follow study procedures, and not have serious heart, liver, kidney issues, major psychiatric disorders, or certain infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cognitive training for 4 weeks, with or without psilocybin administration
Psilocybin Administration
Participants in the psilocybin group receive two oral doses of 25 mg psilocybin, administered two weeks apart
Follow-up
Participants are monitored for safety, cognitive performance, and neuroplasticity changes after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Training
- Psilocybin
Trial Overview
The study compares regular brain-training exercises alone versus brain training combined with psilocybin (a compound from certain mushrooms). Participants are randomly assigned to one of the two groups to see if adding psilocybin improves brain health more than training alone.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
older adults with early-stage AD, two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks
Older adults with normal cognition, two oral doses of 25mg of psilocybin, administered two weeks apart, plus cognitive training for four weeks
older adults with early-stage AD, 4 weeks of cognitive training alone
Older adults with normal cognition, 4 weeks of cognitive training alone
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute on Aging (NIA)
Lead Sponsor
Citations
Impact of psilocybin on cognitive function: A systematic review
Psilocybin was observed to enhance emotional empathy without significantly altering cognitive empathy and social cognition.
Neuroplasticity Enhancement From Cognitive Training ...
this study will provide proof-ofconcept for psilocybin s potential to promote neuroplasticity, enhance cognition, improve emotional well-being, and mitigate ...
Psilocybin therapy increases cognitive and neural flexibility ...
Psilocybin therapy increased cognitive flexibility for at least 4 weeks post-treatment, though these improvements were not correlated with the ...
Human brain changes after first psilocybin use - PMC - NIH
Increases in cognitive flexibility, psychological insight, and well-being are seen at one-month.
Impact of psilocybin on cognitive function: A systematic ...
Psilocybin was observed to enhance emotional empathy without significantly altering cognitive empathy and social cognition. Cognitive ...
Psilocybin for the treatment of Alzheimer's disease - PMC
The effects of psilocybin on cognitive and emotional functions in healthy participants: results from a phase 1, randomised, placebo-controlled trial ...
7.
biologicalpsychiatryjournal.com
biologicalpsychiatryjournal.com/article/S0006-3223(25)00348-8/fulltext13. Safety, Feasibility, and Tolerability of Psilocybin in ...
The preliminary data suggest that psilocybin is a safe, well-tolerated, and feasible potential treatment in older adults with aMCI. Funding Source. Alzheimer ...
8.
alzheimers.gov
alzheimers.gov/clinical-trials/psilocybin-depression-people-mild-cognitive-impairment-or-early-alzheimers-diseasePsilocybin for Depression in People With Mild Cognitive ...
This pilot study will evaluate whether psilocybin, provided in a supervised environment, reduces depression and improves the quality of life in people with mild ...
9.
pure.johnshopkins.edu
pure.johnshopkins.edu/en/publications/the-potential-for-psychedelics-to-improve-coping-skills-and-resil/The Potential for Psychedelics to Improve Coping Skills ...
Pre-clinical research and neuroimaging data suggest potential benefit of psychedelics in Mild Cognitive Impairment and mild Alzheimer's disease. Safety ...
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