Levetiracetam for the treatment of mild cognitive impairment in Parkinson’s disease: a double-blind controlled proof-of-concept trial protocol

Table 1 Participant timeline

Procedures	Screening		Study period				Close-out
Procedures	Enrolment	Day 14 T₀: allocation	Day 0 T₁: baseline	Day 14 T₂: post-assessment 1	Day 44 T₃: end washout period	Day 58 T4: Post-assessment 2	Close-out
Procedure for HC and PD-nMI groups
Informed consent	X
Screening interviews	X
MRI session			X
Procedure for PD-aMCI group
Informed consent	X
Screening interviews	X
Bloodwork	X			X	X	X
Medical assessment	X
Random allocation		X
Dispensing of medication		X			X
Study commencement notification to treating physicians (GP/neurologist)		X
Commence treatment (levetiracetam ↔ placebo)			X		X
Post-treatment assessment				X		X
MRI session				X		X
Telephone check-in (weekly)			X	X	X	X	X
Report to GP/neurologist							X

PD-aMCI Parkinson’s disease with amnestic mild cognitive impairment, PD-nMI Parkinson’s disease without memory impairment, HC Healthy controls, fMRI functional magnetic resonance imaging

ISSN: 2055-5784