Table 1.
Schedule of assessments
| Visit | Screening | Assessment phase | |||||||
| 1* | 2† | 3† | 4 | 5 | 6 | 7 | 8 | 9 | |
| Visit type | Screening | Baseline | Baseline | 1 Month | 2 Months | 6 Months | 8 Months | 10 Months | 12 Months |
| Time (months) | −2 | 0 | 0 | 1 | 2 | 6 | 8 | 10 | 12 |
| Time (days) | −60 to −2 | 1 | 2–5 | 30 | 60 | 180 | 240 | 300 | 365 |
| Visit windows (days) | – | – | +3 | ±14 | ±14 | ±14 | ±14 | ±14 | ±14 |
| Procedures | |||||||||
| Consent | X | ||||||||
| Clinical and cognitive measures | |||||||||
| Clinical interview | X | X | |||||||
| Clinical assessments | X | X | X | ||||||
| CANTAB cognition battery | X | X | X | X | X | X | |||
| EPAD cognition battery | X | X | X | ||||||
| Specimens | |||||||||
| CSF sampling | X‡ | X‡ | X | X | |||||
| Blood, saliva and urine | X | X | X | X | X | X | X | X | |
| Visit | 1* | 2† | 3† | 4 | 5 | 6 | 7 | 8 | 9 |
| Imaging | |||||||||
| PET amyloid | X§ | X§ | |||||||
| PET tau | X¶ | X§ | |||||||
| MRI | X** | X | X | X | X | X | |||
| MEG and EEG | X | X†† | X | ||||||
| Wearable technology and connected devices | |||||||||
| Gait and peripherals‡‡ | X | X | X | ||||||
| Mezurio smartphone application§§ | X | X | X | X | X | X | X | ||
| Indoor localisation system | X | X | X | X | X | ||||
| Outdoor localisation system | X | X | X | X | X | X | X | X | |
| Mood and sleep ratings | X | X | X | X | X | X | X | ||
| Other | |||||||||
| Ophthalmological assessment | X | X | X | ||||||
| Participant acceptability | X | ||||||||
*Screening visit may take place over several appointments.
†Baseline assessments can be performed on Day 1 or Days 2-5 with the exception of PET tau, which can be performed on Days 2-30. See section 11 for further details.
‡CSF Sampling may be carried out as an alternative to PET Amyloid at Screening. In those completing CSF sampling at screening, no additional CSF sampling will be performed at baseline.
§For participants screened using CSF a single PET Amyloid scan will be done at any point during the 12 month study duration.
¶A subset of participants (n=100) will undergo follow-up PET Amyloid at approx. 12 months with PET Tau at baseline and again approx. 12 months later.
**It may be possible in some centres to include one MRI scan at screening, to reduce assessment burden at baseline.
††The MEG and EEG scan at 8 months will be undertaken on participants in some study centres only, subject to funding and capacity. It will be made clear to a participant whether 2 or 3 M/EEG scans are proposed for them.
‡‡7-day gait and continuous assessment with devices for cognition.
§§Mezurio interactions will not coincide with the 7-day gait assessments.
CANTAB, Cambridge Neuropsychological Test Automated Battery; CSF, cerebrospinal fluid; EEG, electroencephalograhy; EPAD, European Prevention of Alzheimer’s Disease; MEG, magnetoencephalography; PET, positron emission tomography.