Daridorexant for Alzheimer's Disease Prevention

(PAD-DORA Trial)

This trial tests whether daridorexant, a medication typically used for sleep, can help maintain brain health. Researchers aim to determine if it can clear proteins that may lead to Alzheimer's disease. The study includes individuals without Alzheimer's, regardless of sleep issues. It may suit those without major memory problems who are not using certain sleep or psychiatric medications. Participants will receive either the actual medication or a placebo (a pill with no active ingredients). As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

You may need to stop taking certain medications to join the trial. Specifically, you cannot use benzodiazepines, z-drugs, certain antidepressants, antipsychotics, or medications that affect the central nervous system. It's best to discuss your current medications with the trial team to see if any changes are needed.

Research has shown that daridorexant is usually well-tolerated. Previous studies highlight its safety, making it a promising option for preventive treatments. However, the safety of daridorexant for use longer than one year remains underexplored, indicating potential unknown risks with long-term use. Prospective trial participants can use this information to discuss any concerns with the research team.¹²³⁴⁵

Researchers are excited about daridorexant for Alzheimer's disease prevention because it offers a novel approach compared to current treatments. Unlike existing medications that generally focus on managing symptoms or slowing progression by targeting neurotransmitter imbalances, daridorexant works as an orexin receptor antagonist. This unique mechanism aims to regulate sleep-wake cycles, which are often disrupted in Alzheimer's patients and may play a role in disease progression. By potentially improving sleep and its associated health benefits, daridorexant could offer a new avenue for preventing or delaying the onset of Alzheimer's, setting it apart from standard treatments like donepezil or memantine.

Studies have shown that daridorexant, a sleep medication, can improve sleep quality. Better sleep may help clear proteins linked to Alzheimer's disease. Although no direct evidence shows that daridorexant prevents Alzheimer's, research suggests it might support brain health by improving sleep, potentially lowering the risk of developing Alzheimer's. In this trial, participants will receive either daridorexant or a placebo to investigate these potential effects further. Ongoing research aims to confirm these effects.¹²³⁴⁶