Evaluating the effect of rapamycin treatment in Alzheimer’s disease and aging using in vivo imaging: the ERAP phase IIa clinical study protocol

Table 2 Visits, follow-ups and their corresponding assessments/examinations

Procedure	Screening and inclusion	Baseline imaging	Phone follow-up 1	Clinical follow-up 1	Phone follow-up 2	Clinical follow-up 2	Follow-up imaging	Clinical follow-up 3
Procedure	Screening and inclusion	-42 to 1 day(s) before first dose	1–3 days after first dose	5–14 days after first dose	23–56 days after first dose (± 14 days)	71–105 days after first dose (± 14 days)	-14 to 27 days after last dose	≤ 28 days after last dose
Check inclusion/exclusion criteria	√	√	√	√	√	√	√	√
Medical history/concomitant medications	√		√	√	√	√		√
Physical and Neurological Examination	√			√		√		√
Instructions for taking the study drug	√	√
Retinal OCT^a		√					√
[¹⁸F]FDG PET and qCT^a		√					√
Head/brain MRI^a		√					√
Cardiovascular MRI^a		√					√
Start treatment with study drug^c		√
Blood collection ^d				√		√^b		√
Lumbar puncture^d	√							√
Cognitive testing^d	√							√
Adverse Events (AE & SAE)			√	√	√	√		√
Study end								√

^aFor the PET, MRI, and the OCT examinations, the order is interchangeable
^bPharmacokinetic testing will consist of a total of 4 blood samples per participant. Blood samples will be collected for determining the concentration of rapamycin as follows: within 1 h prior to administration of rapamycin, at 1 and 3 (± 30 min) hours post administration of rapamycin, and 48 h post administration
^c The first weekly dose of rapamycin will be taken on a weekday, after completing the baseline measurements. The treatment will last for 26 weeks (182 days)
^dIn the event that patients are included where the most recent lumbar puncture and/or blood tests and/or cognitive testing are > 9 months old, one additional visit will be planned for new measurements to function as baseline values

ISSN: 1471-2377