Clinical trials with neuroimaging outcomes

I have worked on clinical trials that used brain MRI measures to explore the mechanisms of action of drugs and nutritional products. These trials have suggested that the brain’s responses to food cues is modified by tirzepatide; that a unique infant formula enhances trajectories of baby brain myelination; and that a multi-nutrient supplement can modify brain functional connectivity among older adults. However, overall I believe that functional MRI methodology for clinical trials is under-developed and that the technique is under-utilized. I organized a workshop whose summary paper described the current state of fMRI utilization in clinical trials.

Publications:

Owen Carmichael, Andrea Hemmingway, Corby Martin, Robert V. Considine, David A. Kareken, Susan Carnell, Ulrike Dydak, Richard D. Mattes, Dave Scott, Tamer Coskun. “fMRI in the GPHH tirzepatide trial. Oral presentation.” American Diabetes Association Conference June 23, 2024

Schneider N, Hartweg M, O'Regan J, Beauchemin J, Redman L, Hsia D, Steiner P, Owen Carmichael, people copy. copy

Carmichael O, D'Sa V, Deoni S. Impact of a Nutrient Formulation on Longitudinal Myelination, Cognition, and Behavior from Birth to 2 Years: A Randomized Clinical Trial. . Nutrients. 2023;15(20). PMCID: PMC10610069. PMID: 37892514.

Carmichael O, Pillai S, Shankapal P, McLellan A, Kay DG, Keller JN. A combination of essential fatty acids, panax ginseng extract, and green tea catechins modifies brain fMRI signals in healthy older adults. . Journal of Nutrition, Health & Aging. 2018; 22:837-846. PMID: 30080229.

King JL, Fearnbach SN, Ramakrishnapillai S, Shankpal P, Geiselman PJ, Martin CK, Murray KB, Hicks JL, McClernon FJ, Apolzan JW, Carmichael OT. Perceptual Characterization of the Macronutrient Picture System (MaPS) for Food Image fMRI. Frontiers in Psychology-Eating Behavior. 2018; 9:17. PMCID: PMC5790788 PMID: 29434559.

Carmichael O, Schwarz AJ, Chatham CH, Scott D, Turner JA, Upadhyay J, Coimbra A, Goodman JA, Baumgartner R, English BA, Apolzan JW, Shankapal P, Hawkins KR. The role of fMRI in drug development. . Drug Discovery Today. 2018 Feb; 23:333-348. PMC5931333 PMID: 29154758.

Grants:

Covance/Lilly
Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6 Week Study with Functional MRI
Role: Co-Investigator

Nestlé Research Center, Nestec Ltd
The Effect of Myelin-Relevant Nutrients in Infant Formula on Brain Myelination and Cognitive Development (CONNECT)
Role: Site PI