Alzheimer's disease, clinical trials, recruitment and retention
Dr. Grill has been the recipient of the National Alzheimer’s Coordinating Center Junior Investigator Award, the Alzheimer’s Association Turken Research Prize, the Community Spirit Award from OPICA Adult Day Services, and the P. Gene and Elaine Smith Term Chair in Alzheimer’s Disease Research. He has been funded by the National Institute on Aging, the National Institute of Neurological Disorders and Stroke, the Alzheimer’s Association, the BrightFocus Foundation, the Hartford Foundation, the American Federation for Aging Research, and the University of California. He is the co-leader of the Internal Ethics Committee and the Recruitment Unit for the NIA-funded Alzheimer's Clinical Trial Consortium. He is the Chair of the Internal Ethics Committee for the Alzheimer’s Disease Cooperative Study. He is a member of the Scientific Advisory Board for Maria Shriver’s Women’s Alzheimer’s Movement and for HFC (formerly Hilarity for Charity). In 2017, he co-chaired a workgroup as part of the NIH’s Inclusion Across the Lifespan workshop, a congressional mandate in the 21st Century Cures Act (P.L. 114-255). He is part of a working group sponsored by the National Institute on Aging and the Alzheimer’s Association charged with creating a national strategy for recruitment to Alzheimer’s disease clinical research. In 2021, he was an invited presenter and contributor to "A Workshop on Biomarkers and Other Pre-Clinical Diagnostics of Alzheimer's Disease," sponsored by the National Institute on Aging and convened by the National Academies of Science, Engineering, and Medicine.
For any new Alzheimer’s disease drug to achieve FDA approval and widespread clinical use, it must be tested in human beings and demonstrated as both safe and efficacious. Studies to test the safety and efficacy of new treatments are called clinical trials. Clinical testing now represents the most costly and difficult phase of developing improved therapies. A major challenge of completing human clinical trials is the timely enrollment of participants who will enable adequate examination of therapeutic hypotheses. Alzheimer’s disease clinical trials now enroll people with Alzheimer’s dementia, people with mild cognitive impairment, and people with healthy memories but who are at increased risk to some day develop dementia. We are engaged in a variety of studies that aim to
• Identify means to improve Alzheimer’s disease clinical trial designs to enable adequate testing in fewer participants,
• Elucidate barriers to clinical trial enrollment in each Alzheimer’s disease population, so that trials and recruitment campaigns can be designed in a manner that maximizes the speed of accrual,
• Understand better which participants are at risk to be lost to follow-up, to guide clinician scientists when enrolling participants in Alzheimer’s disease trials, and
• Investigate the ethical challenges in clinical trials, especially those related to Alzheimer’s disease disclosure, including the disclosure of diagnosis, biomarker results, and genetic testing.
Karlawish J, Grill JD. The approval of Aduhelm risks eroding public trust in research and the FDA. Nature Reviews Neurology. 2021 Jul 15. doi: 10.1038/s41582-021-00540-6. Online ahead of print.
Ryan MM, Gillen DL*, Grill JD*. Reasons for undergoing amyloid imaging among cognitively unimpaired older adults. Annals of Clinical and Translational Neurology. 2021 Jul 6. doi: 10.1002/acn3.51414. Online ahead of print.
Park VT, Grill JD, Zhu J, Nuyen K, Nam B, Tsoh J, Kanaya A, Vuong Q, Bang J, Nguyen NCY, Cho IH, Gallagher-Thompson D, Hinton L, Meyer OL. Asian Americans and Pacific Islanders’ Perspectives on Participating in the CARE Recruitment Research Registry for Alzheimer's Disease and Related Dementias, Aging, and Caregiving Research. Alzheimer's & Dementia: Translational Research & Clinical Interventions. 2021;7:e12195.
Grill JD, Karlawish J. Implications of FDA approval of a first disease-modifying therapy for a neurodegenerative disease on the design of subsequent clinical trials. Neurology. 2021 Jun 4:10.1212/WNL.0000000000012329. doi: 10.1212/WNL.0000000000012329. Online ahead of print. PMID: 34088880
Berkness T. Carrillo, MC, Sperling R, Petersen R, Aisen, P, Flournoy C, Snyder H, Raman R,* Grill JD.* The Institute on Methods and Protocol for Advancement of Clinical Trials in ADRD (IMPACT-AD): A novel clinical trials training program. The Journal of Prevention of Alzheimer’s Disease. 2021;8(3):286-291. doi: 10.14283/jpad.2021.12. PMID: 34101785
Bernstein OM, Grill JD*, Gillen D*. Recruitment and Retention of Participant and Study Partner Dyads in Two Multinational Alzheimer’s Disease Registration Trials. Alzheimer's Research Therapy. 2021 Jan 8;13(1):16. doi: 10.1186/s13195-020-00762-8. PMID: 33419457 PMCID: PMC7791680.
Stites S, Turner RS, Gill J, Gurian A, Karlawish J, Grill JD. Research attitudes questionnaire scores predict Alzheimer’s disease clinical trial dropout. Clinical Trials: Journal of the Society for Clinical Trials. 2021 Jan 10;1740774520982315. doi: 10.1177/1740774520982315. PMID: 33426901.
Ryan M, Cox CG, Witbracht M, Hoang D, Gillen D*, Grill JD*. Using Direct-to-Consumer Genetic Testing Results to Accelerate Alzheimer’s Disease Clinical Trial Recruitment. Alzheimer’s Disease Associated Disorders. 2020 Oct 14. doi: 10.1097/WAD.0000000000000421. Online ahead of print. PMID: 33060367.
Raman R, Quiroz YT, Langford O, Choi J, Ritchie M, Baumgartner M, Rentz R, Aggarwal NT, Aisen P, Sperling R, Grill JD. Disparities by race and ethnicity among adults recruited for a preclinical Alzheimer's disease trial. JAMA Network Open. 2021 Jul 1;4(7):e2114364. doi: 10.1001/jamanetworkopen.2021.14364. PMID: 34228129.
For a complete list of publications, https://www.ncbi.nlm.nih.gov/sites/myncbi/1-3SfzxGmMoQ5/bibliography/42882847/public/?sort=date&direction=ascending
“A Phase II, Proof-of-Concept, Double-Blind-Randomized, Placebo-Controlled Adaptive Design Trial of Nicotinamide.” University of California Office of the President
1R01AG059407-01 (with Dr. Daniel Gillen) Effects of Alzheimer’s disease clinical trial study partners
1R21AG056931 (with Dr. Daniel Gillen) The study partner requirement in preclinical Alzheimer’s disease trials.
BrightFocus Foundation A2018405S, Improving recruitment to prodromal Alzheimer’s disease clinical trials
Associate Director, Alzheimer's Disease Research Center
Director of Accrual and Retention Consult Service, Institute for Clinical and Translational Science
Director, Institute for Memory Impairments and Neurological Disorders