Table 3.
Multicenter AD/ADRD clinical studies supported by the ATRI EDC system (as of August 3, 2021)
| Study | Study type | Start year | Users | Sites | Participants screened | eCRFs |
Queries |
Document repository |
Image studies | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | Transactions | N | Rate (%) | Files | File versions | |||||||
| ABC-DS | OC | 2021 | 22 | 8 | — | — | — | — | NAN | 19 | 19 | — |
| ADNI3 | OC | 2016 | 836 | 63 | 1802 | 136 876 | 152 773 | 11 644 | 8.5 | 1217 | 135 797 | — |
| AHEAD3-45 | RCT | 2020 | 1065 | 108 | 1147 | 63 200 | 69 047 | 9275 | 14.7 | 4161 | 14 333 | 449 |
| COGRX | RCT | 2022 | — | — | — | — | — | — | — | — | — | — |
| LEADS | OC | 2018 | 311 | 19 | 415 | 28 843 | 34 497 | 4919 | 17.1 | 539 | 11 721 | — |
| LIBBY | RCT | 2022 | 12 | — | — | — | — | — | — | — | — | — |
| MIND | RCT | 2017 | 443 | 51 | 623 | 61 656 | 72 588 | 7361 | 11.9 | 446 | 34 040 | — |
| NiAD | OC | 2016 | 102 | 5 | 248 | 20 623 | 24 391 | 2601 | 12.6 | 11 | 4186 | — |
| TRC-PAD | OC | 2019 | 598 | 51 | 360 | 26 592 | 28 545 | 1086 | 4.1 | 486 | 13 740 | 252 |
| TRC-DS | OC | 2021 | 149 | 17 | 1 | 26 | 27 | 1 | 3.8 | 410 | 419 | 2 |
| Total | 3526 | 322 | 4596 | 337 816 | 381 868 | 36 887 | 7289 | 214 255 | 703 | |||
Note: Some sites participate in multiple studies. AD/ADRD RCTs typically experience 50%-80% screen failure rates; participant enrollment is ongoing in all studies. Two new RCTs, COGRX and LIBBY, are currently under development and scheduled to start in 2022.
Abbreviations: ABC-DS: Alzheimer Biomarker Consortium—Down Syndrome; ADNI3: Alzheimer’s Disease Neuroimaging Initiative 3 (ADNI3) Protocol; AHEAD3-45: AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer’s Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid; COGRX: Randomized Double Blind, Placebo Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer’s Disease over 18 Months; LEADS: Longitudinal Early-onset Alzheimer’s Disease Study Protocol; LIBBY: Life’s end Benefits of CannaBidol and TetrahYdrocannabinol (LiBBY) Trial; MIND: Memory Improvement Through Nicotine Dosing (MIND) Study; NIAD: Neurodegeneration in Aging Down Syndrome (NiAD): A Longitudinal Study of Cognition and Biomarkers of Alzheimer’s Disease; TRC-PAD: TRC-PAD Program: In-Clinic Trial-Ready Cohort; TRC-DS: Trial-Ready Cohort-Down Syndrome; OC: observational cohort; RCT: randomized clinical trial.