Article summary
This Phase II, randomised, open-label, parallel-group trial (n=200) will assess whether psilocybin can enhance the neuroplastic and cognitive effects of cognitive training in older adults with early-stage Alzheimer’s disease or normal cognition. Participants aged 65 years and older will receive either cognitive training alone or cognitive training plus two oral doses of psilocybin 25 mg given 2 weeks apart, with the main aim of determining change in a Neuroplasticity Composite Score after 4 weeks. Participants in both population groups will complete 4 weeks of daily tablet-based cognitive training, while those assigned to psilocybin will also have clinic dosing visits and remain under observation for 24 hours after each dose. Key secondary measures include safety and tolerability, cognition, psychological well-being, quality of life, and sleep, alongside MRI/fMRI/MRS, EEG during sleep, and blood-based biomarker assessments of synaptic integrity, serotonergic transmission, neurodegen...
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