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Clinical Trial Summary

We will use cognitive exams, perceptual tasks, brain imaging, peripheral psychophysiology, and surveys to investigate the persisting effects of psilocybin on cognition, predictive coding, and affect in healthy older adults. We will measure changes in these measures by comparing baseline to one-week and one-month post-treatment. Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose. Dose response will be assessed. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. We will assess whether changes in these brain measures underlie observed changes in cognition, predictive coding and affect.


Clinical Trial Description

We will use cognitive exams, perceptual tasks, brain imaging, peripheral psychophysiology, and surveys to investigate the persisting effects of psilocybin on cognition, predictive coding, and affect in healthy older adults. We will measure changes in these measures by comparing baseline to one-week and one-month post-treatment. Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose. Dose response will be assessed. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. We will assess whether changes in these brain measures underlie observed changes in cognition, predictive coding and affect. The data from this study will provide a strong foundation for future studies to further investigate the effects of psychedelic-induced plasticity on cognition, predictive coding and affect. These experimental studies will be conducted in participants with no diagnosable mental health conditions, but the resulting mechanistic insights may inform development of treatments that use psychedelics to help individuals shift from pathological patterns of thought, emotion, and behavior to more healthy and adaptive ones. This information will be crucial for designing and optimizing mental health treatments using psychedelic agents. Furthermore, these studies may also reveal biomarkers that can then be used to predict the likelihood of a patient's response to a particular type of therapeutic intervention. This project will include healthy older adults (60-85 years old), allowing us to characterize the dose-dependent effects of psilocybin, from the acute subjective experience to long-term persisting effects, in old age. Studying the effects of psilocybin in old age may inform the development of treatments that use psychedelics to improve cognition and affect in older adults by promoting brain changes that oppose the effects of synaptic dysfunction in aging and neurodegeneration in Alzheimer's disease. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06367738
Study type Interventional
Source University of California, Berkeley
Contact
Status Not yet recruiting
Phase Phase 1
Start date April 1, 2025
Completion date December 30, 2027

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