Measuring Cognition in Psychedelic-Assisted Therapy Clinical Trials
In his live Table Talk session at the Sana Symposium, Rick Doblin, PhD, Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS), discusses measuring cognition during psychedelic-assisted therapy clinical trials.
Read the transcript:
Dr Doblin: I'm a neuropsychologist working with scales, measuring cognition in Alzheimer's. How do you measure cognition in clinical trials?
We have done neurocognitive batteries in 2 of our clinical trials before and after and shown no difference. Actually, people did slightly better.
That was the RBANS and a whole bunch of batteries. The FDA said there's no real concern anymore about neurotoxicity or cognitive problems. We don't have to do that in Phase III.
We did it in 2 independent Phase III sites with 2 independent neurocognitive assessment batteries, and everything looked fine. All the other research suggests the same.
EEG we don't do. I see this from Shawn. The only difference is that we do have MRIs sometimes, before and after, and there are reductions in activity in the amygdala. We don't have to figure out how it works, basically, to make it a medicine. We prove safety and efficacy.
We're leaving the mechanism of actions for other people. We'll show it works, they can figure out how.
