Table 4.
Key study assessments in the treatment periods of the Generation Program
| Assessment | Every 3 months | Every 6 months | Yearly |
|---|---|---|---|
| Standard safety assessments | Adverse events and concomitant medications (including procedures, non-drug therapies [e.g., physical therapy, blood transfusions]), C-SSRS | Physical and neurological evaluation, laboratory tests, ECGs (also, month 3 in the first year) | – |
| Vital signs | In Generation Study 1 Cohort I (CAD106 or placebo) | In Generation Study 1, cohort II, and Generation Study 2 (umibecestat or placebo) (also, month 3 and 9 in the first year) | – |
| Imaging: MRI (including fMRI) | – | – | In both studies and cohorts (also at month 6 in the first year) |
| Imaging: FDG PET | – | – | In Generation Study 1 at baseline and year 2 |
| Imaging: Amyloid PET | – | – | In Generation Study 1, mandatory at baseline and year 2, optional at year 5. In Generation Study 2, voluntary at baseline (unless used for determination of amyloid status |
| Imaging: Tau PET | – | – | In Generation Study 1, voluntary at baseline, year 2, and year 5 In Generation Study 2, mandatory at baseline, year 2, and year 5 |
| Clinical scales | – | RBANS, Raven's Progressive Matrices, MMSE, CDR, MCI/dementia due to AD diagnostic verification, ECog | GDS, NPI-Q, Lifestyle questionnaire, Qol-AD |
| Blood samples | – | PK and Aβ plasma | Biomarker plasma/serum (Month 6, Years 1, 2, 5, PPW) |
Abbreviations: Aβ, amyloid beta; AD, Alzheimer's disease; CDR, clinical dementia rating; C-SSRS, Columbia–Suicide Severity Rating Scale; ECG, electrocardiogram; ECog, everyday cognition scale; FDG, fluorodeoxyglucose; fMRI, functional magnetic resonance imaging; GDS, geriatric depression scale; MCI, mild cognitive impairment; MMSE, Mini-Mental State Examination; MRI, magnetic resonance imaging; NPI-Q, neuropsychiatric inventory questionnaire; PET, positron emission tomography; PK, pharmacokinetic; PPW, premature participant withdrawal; Qol-AD, quality of life in Alzheimer's disease.