Donepezil Trial for Motor Recovery in Acute Stroke

Not yet recruiting

Phase 1/2 Results N/A

Trial Description

Stroke is a major personal and social burden, being the commonest cause of severe adult disability. Recovery has been shown in animal models to be dependent upon adequate levels of acetylcholine within the brain - which in stroke is likely to be deficient. This is because acetylcholine-producing nerve cells in the brain are often damaged by strokes. Consequently, the investigators hypothesise that recovery may be improved by boosting acetylcholine levels in the brain - that can be readily achieved by treating with donepezil.
AIMS: To establish: 1) whether motor deficits in acute stroke improve more in patients taking donepezil, relative to placebo, for 12 weeks; 2) whether brain functional MRI changes as a result of donepezil after 12 weeks.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Inert pill that appears identical to donepezil pill. 1 pill for first 4 weeks, followed by 2 pills until end of study.
    ARM 1: Kind: Experimental
    Label: Placebo
  • Donepezil Drug
    Other Names: Aricept
    Intervention Desc: 5mg for 4 weeks, 10mg for 8 weeks if tolerated, or lower dose to continue
    ARM 1: Kind: Experimental
    Label: Donepezil

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Upper Extremity Fugl-Meyer Motor Score (out of 66) over 12 weeks 12 weeks No
Secondary Change in Functional MRI Connectivity and Task-related activation (relative % BOLD signal change) over 12 weeks 12 weeks No
Secondary Side-effects 12 weeks Yes
Secondary Number and type of participants with adverse events 12 weeks Yes

Sponsors