TABLE 1.
Schedule of events.
| Visit Name/Month | Baseline | Month 6 | Month 12 | Month 18 | Month 24 |
|---|---|---|---|---|---|
| Informed consent for enrollment, HIPAA | X | ||||
| Demographics, brief physical and neurological exam, ECG, medical history | X | ||||
| Unmasked intake interview | X | X | X | X | |
| Medication review, weight measurement | X | X | X | X | X |
| Vital signs, waist circumference | X | X | X | ||
| Fasting clinical blood labs | |||||
| Comprehensive metabolic panel, hemoglobin/hematocrit | X | X | |||
| Glucose, HbA1c, lipid panel | X | X | X | ||
| Non‐fasting clinical blood labs | |||||
| HbA1c, lipid panel | X | X | |||
| Blood Collection for APOE genotyping and DNA extraction and storage | X | ||||
| Fasting blood collection for banking | X | X | X | ||
| AE monitoring at clinic | X | X | X | X | |
| POINTER modified neuropsychological test battery (Free and Cued Selective Reminding Test, Story Recall, Visual Paired Associates, Number Span, Word Fluency, Digit Symbol Substitution Test, Trail‐Making test) | X | X | X | X | X |
| Digital cognition technologies clock drawing test, BrainHQ assessment, MMSE | X | X | X | X | X |
| C‐3: Cogstate detection, identification, one back, one‐card learning, face name associative memory exam, behavioral pattern separation of objects | X | X | X | ||
| CDR, IADL, ECog, SF‐36, EQ5D, CFI | X | X | X | ||
| Sleep questionnaire | X | X | X | X | X |
| Lifestyle questionnaires (physical activity, sitting habits, rush food frequency, cognitive activity), sleep questionnaire, GDS | X | X | X | X | X |
| 400 Meter Walk Test, SPPB | X | X | X | ||
| Randomization | X | ||||
| Obtain participant feedback and exit interview | X |
Abbreviations. AE, adverse event; APOE, apolipoprotein E, C‐3: Cogstate Battery; CDR, Clinical Dementia Rating, CFI: Cognitive Function Index; DNA, deoxyribonucleic acid; ECG, electrocardiography; ECog, Everyday Cognition; GDS, Geriatric Depression Scale; HbA1c, glycated hemoglobin; HIPAA, Health Information Portability and Accountability Act; IADL, independent activities of daily living; MMSE, Mini‐Mental Status Exam; SF‐36 and EQ5D, quality of life scales; SPPB, Short Physical Performance Battery.