This Phase I/II randomised, triple-blind, placebo-controlled trial (n=20) will study the effects of sublingual 5-MeO-DMT (6 mg, administered weekly for four weeks) on anxiety, depression, and cognitive function in individuals with mild to moderate Alzheimer's disease.
Randomized, triple-blind, placebo-controlled Phase I/II trial in participants with mild to moderate Alzheimer's disease or MCI (n=20). Participants are assigned 1:1 to sublingual 5-MeO-DMT 6 mg or matched placebo, administered once weekly for four weeks.
Primary assessments include cognitive measures (ACE-III, CDR, IFS, RAVLT, TMT, PASAT, DSS) and psychiatric inventories (BDI-II, STAI, SSI); safety monitoring comprises vital signs, ECGs, biochemical panels, and adverse-event tracking.
The study evaluates short-term and cumulative effects of low-dose sublingual 5-MeO-DMT on cognition, anxiety, and depressive symptoms in older adults, with EEG and subjective psychedelic-effect ratings captured acutely.
Sublingual 6 mg once weekly for four weeks.
Sublingual administration once weekly for four consecutive weeks.
Placebo sublingual formulation once weekly for four weeks.
Placebo matched to appearance and administration of active arm.