ABSTRACT
Background: The increasingly appreciated intersection between epilepsy and Alzheimer's disease offers potential therapeutic opportunity. We therefore initiated a pragmatic pilot study to explore whether the anti-seizure medication levetiracetam might offer benefit to people with Alzheimer's disease. Methods: The Investigation of Levetiracetam in Alzheimer's Disease (ILiAD) trial is a randomised, double-blind, placebo-controlled trial. ILiAD recruits people with mild to moderate Alzheimer's disease who have not previously had a seizure and in whom a routine electroencephalogram is normal. The primary outcome is change in a touchscreen memory task. Secondary outcomes include effect on mood, alterations in quality of life and carer-reported outcomes. Results: ILiAD plans to recruit 30 participants. To date, eight people have completed both arms of the study with no withdrawals from those enrolled. The COVID-19 pandemic has had multiple severe impacts on both study recruitment and assessments. The primary outcome measure, in particular, has proved difficult to evaluate during the pandemic owing to many assessments being done remotely. Conclusion: ILiAD is a pilot study that is part of the vanguard of trials exploring the potential role of anti-seizure medications, particularly levetiracetam, in people with Alzheimer's disease. Further work seems important to better understand whether drugs specifically designed to modulate cortical excitability may offer improvement in cognition for those with neurodegenerative disorders.