Abstract
The Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer’s Disease (ADAD) trial evaluates the anti-amyloid-β antibody crenezumab in cognitively unimpaired persons who, based on genetic background and age, are at high imminent risk of clinical progression, and provides a powerful test of the amyloid hypothesis. The Neurosciences Group of Antioquia implemented a pre-screening process with the goals of decreasing screen failures and identifying participants most likely to adhere to trial requirements of the API ADAD trial in cognitively unimpaired members of Presenilin1 E280A mutation kindreds. The pre-screening failure rate was 48.2%: the primary reason was expected inability to comply with the protocol, chiefly due to work requirements. More carriers compared to non-carriers, and more males compared to females, failed prescreening. Carriers with illiteracy or learning/comprehension difficulties failed pre-screening more than non-carriers. With the Colombian API Registry and our prescreening efforts, we randomized 169 30-60 year-old cognitively unimpaired carriers and 83 non-carriers who agreed to participate in the trial for at least 60 months. Our findings suggest multiple benefits of implementing a pre-screening process for enrolling prevention trials in ADAD.
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References
Peterson RC: Barriers for prevention and prodromal AD trials. J Prev Alz Dis 2016; 3:66–67.
Reiman EM, Langbaum JB, Tariot PN, et al. CAP-advancing the evaluation of preclinical Alzheimer disease treatments. Nat Rev Neurol 2016; 12:56–61.
Sperling R, Cummings M, Donohue M, Aisen P. Global Alzheimer’s Platform Trial Ready Cohorts for the Prevention of Alzheimer’s Dementia. J Prev Alz Dis 2016; 3:185–187.
Reiman EM, Langbaum JB, Fleisher AS, et al. Alzheimer’s Prevention Initiative: a plan to accelerate the evaluation of presymptomatic treatments. J Alzheimers Dis 2011; 26 Suppl 3:321–329.
Calamia M, Bernstein JP, Keller JN. I’d Do Anything for Research, But I Won’t Do That: Interest in Pharmacological Interventions in Older Adults Enrolled in a Longitudinal Aging Study. PLoS One 2016; 11:e0159664.
Gauthier S, Albert M, Fox N, et al. Why has therapy development for dementia failed in the last two decades? Alzheimers Dement 2016; 12:60–64.
Fargo KN, Carrillo MC, Weiner MW, Potter WZ, Khachaturian Z. The crisis in recruitment for clinical trials in Alzheimer’s and dementia: An action plan for solutions. Alzheimers Dement 2016; 12:1113–1115.
Watson JL, Ryan L, Silverberg N, Cahan V, Bernard MA. Obstacles and opportunities in Alzheimer’s clinical trial recruitment. Health Aff (Millwood) 2014; 33:574–579.
Rios-Romenets S, Lopez H, Lopez L, et al. The Colombian Alzheimer’s Prevention Initiative (API) Registry. Alzheimers Dement 2017; 13:602–605
Acosta-Baena N, Sepulveda-Falla D, Lopera-Gomez CM, et al. Pre-dementia clinical stages in presenilin 1 E280A familial early-onset Alzheimer’s disease: a retrospective cohort study. Lancet Neurol 2011; 10:213–220.
Grill JD, Karlawish J, Elashoff D, Vickrey BG. Risk disclosure and preclinical Alzheimer’s disease clinical trial enrollment. Alzheimers Dement 2013; 9:356–359 e351.
Bobzean SA, DeNobrega AK, Perrotti LI. Sex differences in the neurobiology of drug addiction. Exp Neurol 2014; 259:64–74.
McRae AL, Hedden SL, Malcolm RJ, Carter RE, Brady KT. Characteristics of cocaine-and marijuana-dependent subjects presenting for medication treatment trials. Addict Behav 2007; 32:1433–1440.
Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment due to Alzheimer’s disease: recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement 2011; 7:270–279.
Quiroz YT, Schultz AP, Chen K, et al. Brain Imaging and Blood Biomarker Abnormalities in Children With Autosomal Dominant Alzheimer Disease: A Cross-Sectional Study. JAMA Neurol 2015; 72:912–919.
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Rios-Romenets, S., Giraldo-Chica, M., López, H. et al. The Value of Pre-Screening in the Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer’s Disease Trial. J Prev Alzheimers Dis 5, 49–54 (2018). https://doi.org/10.14283/jpad.2017.44
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DOI: https://doi.org/10.14283/jpad.2017.44