Abstract Body

Objectives: The overall goals of the Alzheimer’s Disease Neuroimaging Initiative (ADNI) are to validate biomarkers for AD clinical trials and to provide data for design of clinical trials. Since ADNI began in 2004 [1], we have enrolled over 2000 participants :and followed them longitudinally with MRI, amyloid and tau PET, and CSF biomarkers, genetics, plasma analysis, and neurocognitive tests. All ADNI data is shared on LONI leading to more than 4500 publications [2].

Methods: ADNI4 [3] has several new features: 1) To address the problem of lack of generalizability of AD clinical research, ADNI4 will recruit 50-60% of all new participants from Under-Represented Populations (URPs), such as Black/African-American, Latino/Hispanic, Asian, and people with high school education or less. This will be accomplished with an ambitious Community Engaged Research Approach, using recruiters at “hub sites.” 2) To efficiently identify and enroll URPs, ADNI4 will use a digital marketing campaign with locally branded racial/ethnically tailored websites to recruit a large pool of participants (n=20,000) who will be remotely screened. Initially, an online portal will capture demographic information and cognitive assessments including the self-report ECog and Novoic’s Storyteller recall test, which uses participant speech. A second screening (n=4000) will use blood-biomarker tests to maximize enrollment of participants thought to have AD pathology. Results from these remote participants will be used to refer participants to ADNI clinics for full in-clinic characterization. ADNI4 expects to maintain 500 rollovers and enroll 500 new participants in-clinic.

Results & Conclusions: Plasma will be analyzed for amyloid 42/40, p-Tau species, NfL, and other analytes, using MS and IM assays. All data will be available on the ADNI website, providing a model for future clinical trials.