ADNI Clinical Core and Cohorts Summary
Learn about the ADNI Clinical Core and Cohorts led by Ron Petersen and Paul Aisen. Explore eligibility criteria for CN, MCI, and Mild AD cohorts, along with the schedule of events and new components in ADNI3. Find out more about the research and protocols involved in this study.
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ADNI Clinical Core Ron Petersen & Paul Aisen July 20, 2018
ADNI3 Cohorts CN MCI Mild AD
3 CN Eligibility Criteria Age initially 65-90, but may adjust to match other cohorts With or without subjective memory complaints CDR=0 MMSE 24-30 Logical Memory >=9 for 16+ years of education >=5 for 8-15 years of education >=3 for 0-7 years of education No cholinesterase inhibitors or memantine
4 MCI Eligibility Criteria Age 55-90 Subjective memory concern by participant, study partner or clinician CDR=0.5 MMSE 24-30 Logical Memory <=11 for 16+ years of education <=9 for 8-15 years of education <=6 for 0-7 years of education Stable cholinesterase inhibitors and memantine allowed
5 Mild AD Eligibility Criteria Age 55-90 Subjective memory concern by participant, study partner or clinician CDR=0.5 or 1 MMSE 20-26 Logical Memory <=8 for 16+ years of education <=4 for 8-15 years of education <=2 for 0-7 years of education Diagnosis of probable AD Stable cholinesterase inhibitors and memantine allowed
ADNI3: Schedule of Events Rollover and New Subjects Baseline 12 month 24 month 36 month 48 month Phone Check OR CV, MRI, Tau (+/-) CV, MRI, Tau, AMY, LP CV, MRI, Tau (+/-), AMY, LPPhone CheckCV, MRI, Tau, CN AMY, LP CV, MRI, Tau, AMY, LP, FDG CV, MRI, Tau (+/-) CV, MRI, AMY, LP, Tau (+/-) CV, MRI, Tau, AMY, LP MCI CV, MRI, CV, MRI, Tau, AMY, LP, FDG Phone Check (Neuropath only) Phone Check (Neuropath only) CV, MRI, Tau, AMY, LP AD CV, MRI, Tau All rollover and new subjects have a full clinic visit, LP and PET scans during their Initial visit of ADNI 3 CN: visits q2 years unless selected additional Year 3 Tau visit/scans MCI: annual visits; some will have Year 2, 3 Tau PET AD: annual for first 2 years
New components of ADNI3 MINT (instead of Boston naming) Cogstate FCI-SF BHR
The ADNI Study Informing the design of therapeutic trials by looking at clinical, imaging, biomarker, and genetic characteristics across NL, MCI, and AD cohorts ADNI1 2004-2009 ADNIGO 2009-2011 ADNI2 2011-2016 ADNI3* 2016-2021 Duration Sample Size 800 200 EMCI 1180 615 Cohorts NL, MCI, AD NL, SMC, EMCI, LMCI,AD NL, MCI, AD *ADNI3 enrollment began 2016
ADNI3 Updates Total Sites approved: 57/59 Total Enrollment*: 615 Rollover Participants: 375 New Participants: 240 Screen-fails: 125 *Enrollment is measured by the number of Registry eCRFs at Baseline and Initial visit and does not include screening visits
ADNI3 Overall Participants CN MCI N = 138 77.2 ( 7.7) 82 (59%) 56 (41%) 16.1 ( 2.7) 31 (41%) 45 (59%) 11 ( 8%) 127 (92%) AD Combined N = 615 75.9 ( 8.1) 294 (48%) 321 (52%) 16.6 ( 2.5) 115 (41%) 163 (59%) 60 (10%) 555 (90%) Overall Age (years) Male Female Education Amyloid Positive Amyloid Negative Minority Not Minority Race Am Indian/Alaskan Asian Hawaiian/Pacific Islander Black or African American White More than one race Unknown Ethnicity Hispanic or Latino Not Hispanic or Latino Unknown MMSE FCI CDR-SB ADAS13 N = 342 74.7 ( 7.5) 145 (42%) 197 (58%) 16.9 ( 2.3) 56 (34%) 110 (66%) 39 (11%) 303 (89%) N = 47 79.6 ( 9.4) 23 (49%) 24 (51%) 15.6 ( 2.5) 24 (89%) 3 (11%) 1 ( 2%) 46 (98%) 1 ( 0%) 8 ( 2%) 0 ( 0%) 11 ( 3%) 315 (92%) 6 ( 2%) 1 ( 0%) 0 ( 0%) 0 ( 0%) 0 ( 0%) 5 ( 4%) 131 (95%) 2 ( 1%) 0 ( 0%) 0 ( 0%) 0 ( 0%) 0 ( 0%) 0 ( 0%) 46 (98%) 1 ( 2%) 0 ( 0%) 1 ( 0%) 8 ( 1%) 0 ( 0%) 20 ( 3%) 573 (93%) 11 ( 2%) 2 ( 0%) 15 ( 4%) 325 ( 95%) 2 ( 1%) 29.1 ( 1.2) 67.7 ( 6.3) 0.1 (0.3) 13.5 ( 4.3) 3 ( 2%) 134 ( 97%) 1 ( 1%) 27.8 ( 2.3) 59.8 (13.1) 1.4 (1.4) 20.5 ( 6.8) 0 ( 0%) 47 (100%) 0 ( 0%) 20.2 ( 5.9) 40.9 (19.6) 6.7 (3.7) 36.7 ( 9.7) 21 ( 3%) 590 ( 96%) 4 ( 1%) 28.0 ( 3.3) 64.0 (11.9) 1.2 (2.7) 17.3 ( 8.8)
Enrollment challenges Minority enrollment only 10% Very slow enrollment of MCI and AD cohort Plans: Supplemental recruitment funds to all sites Additional pilot site activity awards Focus on diversity efforts, tracking efficacy of tactics Central and local media outreach New participant transportation initiative
ADNI3 Clinical Core Co-DIRECTORS: Paul Aisen Ron Petersen PROJECT & DATA MANAGEMENT: Devon Gessert Jennifer Salazar Yuliana Cabrera Sarah Walter Lindsey Hergesheimer BIOSTATISTICS: Mike Donohue Rema Raman Chung-Kai Sun MEDICAL SAFETY: Mike Rafii Tiffany Chow REGULATORY AFFAIRS: Elizabeth Shaffer Brittney Sloan RECRUITMENT: Shelley Moore Charissa Barger INFORMATICS: Gus Jimenez ADMINISTRATION: Debbie Tobias Jeremy Pizzola
