Psilocybin + Cognitive Training for Alzheimer's Disease

SD
DI
Overseen ByDimitrios I Kapogiannis, M.D.
Age: 65+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute on Aging (NIA)
Must be taking: Acetylcholinesterase inhibitors, Memantine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

DI

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

I am able to understand and agree to participate in this study.
Stated willingness to comply with all study procedures and availability for the duration of the study
I am 65 years old or older.
See 10 more

Exclusion Criteria

I have insulin-dependent diabetes, kidney problems, or high liver test results.
I have tested positive for HIV, hepatitis B or C, or have anemia.
I am not taking antipsychotics or multiple antidepressants, and I do not use fluoxetine.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants undergo cognitive training for 4 weeks, with or without psilocybin administration

4 weeks
5-9 visits (in-person)

Psilocybin Administration

Participants in the psilocybin group receive two oral doses of 25 mg psilocybin, administered two weeks apart

4 weeks
2 visits (in-person, 24-hour stay)

Follow-up

Participants are monitored for safety, cognitive performance, and neuroplasticity changes after treatment

4 weeks
2 visits (in-person)

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

Group I: early-stage Alzheimer's Disease (AD) population - cognitive training plus psilocybinExperimental Treatment2 Interventions
Group II: Normal Cognition population - cognitive training plus psilocybinExperimental Treatment2 Interventions
Group III: early-stage Alzheimer's Disease (AD) population - cognitive training onlyActive Control1 Intervention
Group IV: Normal Cognition population - cognitive training onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute on Aging (NIA)

Lead Sponsor

Trials
1,841
Recruited
28,150,000+

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.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39354706/

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 ...

13. 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 ...

Psilocybin 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 ...

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 ...