Plain-English translation of NCT03082755 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Alzheimer Disease research guide →Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.
This trial is testing , a medication already approved by the FDA for restless legs syndrome, to see if it can reduce nighttime agitation and sleep problems in people with Alzheimer's disease. Researchers have discovered that about one-quarter of people with dementia have an undiagnosed condition called restless legs syndrome that may be causing their nighttime restlessness. This study will test whether treating this underlying condition with the medication improves nighttime agitation and sleep.
Nighttime agitation and sleep disturbance in people with Alzheimer's disease cause suffering and disrupt their caregivers' lives, but current medications used to treat these problems—like antipsychotics and sleep aids—are not very effective and can cause serious side effects like falls and strokes. This trial exists to find a safer, more targeted treatment by addressing a specific, treatable cause that may be overlooked: restless legs syndrome.
You likely qualify if…
You likely don't qualify if…
You would take either the active medication or a placebo (a pill with no active ingredient) once daily in the evening for 8 weeks, then gradually stop taking it over 1 week. The study lasts about 9 weeks total. A nurse will teach your caregiver how to give you the medication and will monitor you for any side effects. Researchers will track your nighttime agitation and sleep patterns throughout the study to see if the medication helps.
AI-generated summary from trial data · Jul 1, 2026 · Not medical advice
United States