Neiloufar Family, PhD
Eleusis Benefit Corporation
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Low Dose Lysergic Acid Diethylamide (LSD) in Healthy Volunteers
Research has shown that psychedelics, such as lysergic acid diethylamide (LSD), have profound anti-inflammatory properties mediated by 5-HT2A receptor signalling, supporting their evaluation as a therapeutic for neuroinflammation associated with neurodegenerative disease such as Alzheimer Disease (AD).
This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered repeat dosing of microdoses of LSD. Here, we present safety and tolerability data, pharmacokinetics, and pharmacodynamic measures that relate to safety, tolerability, and dose response. This was a phase 1 double-blind, placebo-controlled, randomized study. Volunteers were randomly assigned to 1 of 4 dose groups (5 µg, 10 µg, 20 µg LSD, and placebo), and received their assigned dose on six occasions (i.e. every 4 days).
Results and conclusions
Forty-eight older healthy volunteers (mean age = 62.9 yrs), received placebo (n=12), 5 µg (n=12), 10 µg (n=12), or 20 µg (n=12) LSD. LSD plasma levels were undetectable for the 5 µg group and peak plasmatic levels for the 10 µg and 20 µg groups occurred at 30 minutes with an overall terminal half-life of 8.25 hours ± 1.6 (SE) . LSD was well tolerated and the frequency of adverse events was no higher than for placebo. Assessments of cognition, balance, and proprioception revealed no impairment. Our results suggest safety and tolerability of microdoses of LSD every four days and support further clinical development of LSD for the treatment and prevention of AD.
Neiloufar Family is the Director of Research at Eleusis, with specific oversight over the firm’s development of psychiatric therapeutics. She has overseen the planning, conduct, and analysis of two Phase 1 clinical trials investigating the therapeutic potential of LSD. Neiloufar previously did research on language and cognition as a post-doctoral fellow at the University of Kaiserslautern, and led a study on LSD’s effects on language in collaboration with Imperial College London.