Table 3 Description of the simulated trials
From: Forecasting individual progression trajectories in Alzheimer’s disease
Clinical trial description | Inclusion/exclusion criteria | Primary outcome (annual rate of change of…) | Trial duration window | Inspiration from existing AD trial (ClinicalTrials.gov identifier) |
|---|---|---|---|---|
Participants at risk of AD onset | - Age [59.9, 76.1] - CDR global = 0 - MMSE ≥ 24 − 1 risk factor of: > Homozygous APOE-ε4 > Heterozygous APOE-ε4 & Amyloid+ (*) | MMSE | 4 years ± 12 months | Novartis Generation S2 (NCT03131453) |
Preclinical AD with high brain amyloid levels | - Age [54.9, 81.1] - CDR global = 0 - MMSE ≥ 27 - Amyloid+ (*) | ADAS-Cog13 | 4 years ± 12 months | Eisai AHEAD A45 (NCT04468659) |
Early AD with high brain amyloid levels | - Age [49.9, 86.1] - CDR global = 0.5 - MMSE ≥ 24 - Amyloid+ (*) | - MMSE - CDR-SB | 1.5 years ± 6 months | Biogen EMERGE / ENGAGE (NCT02477800 & NCT02484547) |
Early AD with high brain tau levels | - Age [54.9, 81.1] - CDR global = 0.5 - p-Tau+ (*) | ADAS-Cog13 | 4.5 years ± 6 months | Janssen Autonomy (NCT04619420) |
MCI probably due to AD or mild AD | - Age [54.9, 86.1] - CDR global = 0.5 or 1 - From AD data sets | MMSE | 3 years ± 9 months | / |
