TABLE 1.
Data sources and inclusion criteria for model building and validation.
| Study | Role(s) | Primary end point(s) | MMSE scores for inclusion | CDR‐GS for inclusion | Disease category | Number of participants used for modeling (n) | Age range for inclusion (years) | Pathology inclusion criteria | Duration of study | |
|---|---|---|---|---|---|---|---|---|---|---|
| Real‐world data | ADNI | Model building | 1. Serial MRI, PET, other biological markers, and clinical and neuropsychological assessments can be combined to measure the progression of MCI and early AD |
Normal: 24–30 MCI: 24–30 Mild AD: 20–26 |
Normal: 0 MCI: 0.5 Mild AD: 0.5 or 1 |
Normal‐ to mild AD | 2033 total, (459 amyloid‐positive, prodromal AD) | 55–90 | Yes (for inclusion in model‐building dataset), CSF Aβ42 or Aβ PET | Initiated 2003, data extracted February 2, 2020 |
| Gantenerumab | SCarlet RoAD a | Model building, internal validation |
1. Mean change from baseline in CDR‐SB total score 2. AEs/SAEs (OLE phase) |
24–30 | 0.5 | Prodromal AD | 266 | 50–85 | Yes, CSF Aβ42 | 104 weeks |
| Marguerite RoAD | Model building, internal validation |
1. Mean change from baseline in ADAS‐Cog 13 score 2. Mean change from baseline in ADCS‐ADL score 3. AEs/SAEs |
20–26 | 0.5–1.0 | Mild AD | 195 | 50–89 | CSF consistent with amyloid pathology | 104 weeks | |
| Crenezumab | ABBY | Model building, internal validation |
1. Change in ADAS‐Cog score. 2. Change in CDR‐SB |
18–26 | >0.5 | Mild–moderate AD | 144 | 50–80 | Participants were assumed to be amyloid‐positive | 68 weeks |
| BLAZE | Model building, internal validation | 1. Change in brain amyloid load, as assessed by amyloid PET imaging | 18–26 | >0.5 | Mild–moderate AD | 29 | 50–80 | Yes, Aβ PET | 68 weeks | |
| CREAD | External validation | 1. Change from baseline in CDR‐SB | ≥22 | 0.5 or 1.0 | Prodromal‐mild AD | 407 | 50–85 | Yes, CSF Aβ42 | 100 weeks | |
| CREAD2 | External validation | 1. Change from baseline in CDR‐SB | ≥22 | 0.5 or 1.0 | Prodromal‐mild AD | 398 | 50–85 | Yes, CSF Aβ42 | 100 weeks |
Abbreviations: AD, Alzheimer's disease; ADAS‐Cog 13; Alzheimer's Disease Activity Scale – Cognitive subscale 13; ADCS‐ADL, Alzheimer's Disease Cooperative Study – Activities of Daily Living; ADNI, Alzheimer's Disease Neuroimaging Initiative; AE, adverse event; Aβ, amyloid‐beta; CDR‐GS, Clinical Dementia Rating – Global Score; CDR‐SB, Clinical Dementia Rating – Sum of Boxes; CSF, cerebrospinal fluid; MCI, mild cognitive impairment; MMSE, Mini‐Mental State Examination; MRI, magnetic resonance imaging; OLE, open‐label extension; PET, positron emission tomography; SAE, serious adverse event.
Participants in the SCarlet RoAD trial were not receiving memantine or cholinesterase inhibitors.