Plain-English translation of NCT04516057 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether —a medication already approved by Health Canada for other uses—can help reduce agitation in people with Alzheimer's disease. Agitation is one of the most difficult symptoms to treat in Alzheimer's, causing distress for both patients and caregivers. Early research suggests this medication might work better and be safer than current treatment options.
Agitation in Alzheimer's disease is common and very difficult to treat with current medications, which often don't work well and can cause serious side effects. This trial exists because researchers want to find a safer, more effective option to help people with Alzheimer's and reduce the burden on their caregivers.
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You will be randomly assigned to receive either the medication or a placebo (an inactive capsule) for 8 weeks. You will take capsules daily, with doses gradually increased up to a maximum of 2 mg per day if you are in the medication group. Throughout the study, you and your caregiver will attend visits where researchers will assess your agitation, mood, thinking, pain, nutrition, and overall well-being. After the 8-week treatment period ends, you will continue to be followed for another 8 weeks to monitor how you are doing.
AI-generated summary from trial data · Jun 13, 2026 · Not medical advice
Canada