Gabis 2019.
Methods | 12‐week cross‐over trial of donepezil versus placebo |
Participants | Inclusion criteria:
Exclusion criteria:
Location/setting: Israel Sample size: target of 84 participants Number randomised: 60 in total (donepezil + choline (29) or placebo (31)) Number analysed: 48 (intervention (23), placebo (25)) Number and reason for dropouts: 14 were reported to have dropped out ("Six subjects dropped out after the first assessment due to lack of compliance, and three additional subjects subsequently failed to attend follow‐up for the second assessment. Three subjects (one in the placebo group and two in the treatment group) were excluded during treatment due to side effects"). Gender: not reported Mean age: not reported IQ: not reported Concomitant medications: not reported Previous medications: not reported |
Interventions | Intervention (donepezil + choline) for 12 weeks: maximum donepezil 5 mg/day taken once daily, choline 250 mg/day (children up to 40 kg) or 500 mg/day (children 40 kg and over) Comparator (placebo) for 12 weeks: equivalent placebo |
Outcomes | Primary outcomes: AEs Secondary outcomes: none reported Timing of outcome assessments: baseline, weeks 4, 8 and 12 (endpoint) |
Notes | Study start date: March 2010 Study end date: December 2017 Source of funding: not reported Conflicts of interest: not reported |