@article{4018f84a801047c4bcba1a8248ec23c2,
title = "Study rationale and baseline data for pilot trial of dronabinol adjunctive treatment of agitation in Alzheimer's dementia (THC-AD)",
abstract = "Agitation is a common complication of Alzheimer's dementia (Agit-AD) associated with substantial morbidity, high healthcare service utilization, and adverse emotional and physical impact on care partners. There are currently no FDA-approved pharmacological treatments for Agit-AD. We present the study design and baseline data for an ongoing multisite, three-week, double-blind, placebo-controlled, randomized clinical trial of dronabinol (synthetic tetrahydrocannabinol [THC]), titrated to a dose of 10 mg daily, in 80 participants to examine the safety and efficacy of dronabinol as an adjunctive treatment for Agit-AD. Preliminary findings for 44 participants enrolled thus far show a predominately female, white sample with advanced cognitive impairment (Mini Mental Status Examination mean 7.8) and agitation (Neuropsychiatric Inventory-Clinician Agitation subscale mean 14.1). Adjustments to study design in light of the COVID-19 pandemic are described. Findings from this study will provide guidance for the clinical utility of dronabinol for Agit-AD. ClinicalTrials.gov Identifier: NCT02792257. ",
keywords = "Alzheimer's disease, agitation, dementia, drug trials, neuropsychiatric symptoms",
author = "Cohen, {Leah M.} and Eleanor Ash and Outen, {John D.} and Ryan Vandrey and Halima Amjad and Marc Agronin and Burhanullah, {M. Haroon} and Patricia Walsh and Wilkins, {James M.} and Leoutsakos, {Jeannie Marie} and Nowrangi, {Milap A.} and David Harper and Rosenberg, {Paul B.} and Forester, {Brent P.}",
note = "Funding Information: R. Vandrey received compensation as a consultant or advisory board member from Canopy Health Innovations, FSD Pharma, and Present Life Corporation in the past year. J. Wilkins is supported by grant funding from the Alzheimer{\textquoteright}s Association. D. Harper is supported by grant funding from the National Institute on Aging, the Spier Family Foundation, The Rogers Family Foundation, Eli Lilly and Biogen. P. Rosenberg is supported by grant funding from the National Institute on Aging, Alzheimer{\textquoteright}s Association, Lilly, Functional Neuromodulation, Vaccinex, the Alzheimer{\textquoteright}s Disease Cooperative Study (ADCS), Alzheimer{\textquoteright}s Disease Trials Research Institute (ATRI), and the Alzheimer{\textquoteright}s Clinical Trials Consortium (ACTC); he has served as a consultant to GLG, Leerink, Otsuka, Avanir, ITI, IQVIA, Food and Drug Administration, Cerevel, Bioxcel, Sunovion, and Acadia. B. Forester is supported by grant funding from the National Institute on Aging, the Spier Family Foundation, The Rogers Family Foundation, Eli Lilly, Eisai and Biogen; he serves as a consultant to Biogen and Acadia Pharmaceuticals. The remaining authors only declare the National Institute on Aging grant R01AG050515 that supported the conduct of this trial. Publisher Copyright: {\textcopyright} International Psychogeriatric Association 2021.",
year = "2021",
doi = "10.1017/S1041610221001150",
language = "English (US)",
pages = "1--6",
journal = "International psychogeriatrics",
issn = "1041-6102",
publisher = "Cambridge University Press",
}