Table 1.

Schedule of enrolment, interventions, and assessment (according to the SPIRIT guidelines)

T0 = Recruitment, Informed Consent, Randomization; T1 = before the first treatment arm (neuropsychology, neuroimaging and blood sample assessment); T2 = after the first treatment arm (neuropsychology, neuroimaging and blood sample assessment); T3 = after the wash-out period and before the second treatment arm (neuropsychology, neuroimaging and blood sample assessment); T4 = after the second treatment arm (neuropsychology, neuroimaging and blood sample assessment); IP Investigational product

*additional weekly phone-calls to assess adverse events

¹Working memory, inhibition, cognitive flexibility, neural activation during working memory fMRI

²IQ, memory, fine motor speed, attention

³Voxel-based morphometry, diffusion tensor imaging, resting-state functional imaging, arterial spin labeling, magnetic resonance spectroscopy