Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life

The LONG-LIFE study is a randomized Phase I, dose-ranging trial designed to evaluate whether psilocybin impacts aging-related biomarkers, cognitive function, and purpose/meaning in life in medically stable older adults. Up to 50 participants will be enrolled aged 60-80 who will be randomized with equal allocation to one of four intervention groups: (1) receipt of one 25 mg dose of psilocybin; (2) receipt of two 25 mg doses of psilocybin separated by four weeks; (3) receipt of three 25 mg doses, with each dose separated by four weeks; or (4) wait-list comparator condition that does not receive psilocybin. Biomarkers of aging, cognitive performance, and behavioral measures will be assessed at baseline and longitudinally over a 12-month follow-up period. The primary endpoint occurs at the Week 16 visit. Participants randomized to the wait-list condition will be offered a single 25 mg dose of psilocybin following conclusion of the 12-month follow-up period. Findings from this Phase I study will inform dose selection for a Phase II study should results indicate a potential impact of psilocybin on relevant study endpoints.

Inclusion Criteria: * English speaking and able to provide informed consent and complete study procedures * Medically healthy, as determined by the screening physician, with no significant medical conditions that would interfere with participation or affect the safety of the subject. Exclusion Criteria: * History or presence of any psychiatric or medical condition that, in the opinion of the investigator, could pose a safety risk, interfere with participation, or confound study results. * Abnormal ECG at screening that may increase risk during participation (e.g., prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician). * Unwilling or unable to discontinue medications that may interfere with study participation, as determined by the investigator.