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Yes! A positive Phase 3 treatment study for symptoms of dementia

By September 19, 2019Commentary, In the News

Contributed by David Sultzer, MD, Professor of Psychiatry & Human Behavior

Last week, Acadia Pharmaceuticals announced findings from its trial of pimavanserin for treatment of delusions and hallucinations related to dementia: Participants treated with pimavanserin had better outcomes than those treated with placebo.

The study design was different from usual treatment comparisons of drug and placebo.  In this trial, all participants with psychosis symptoms along with Alzheimer’s disease or another cognitive disorder were treated with pimavanserin for 12 weeks.  Those who showed improvement were then assigned to either continue taking the drug or cross over to placebo treatment.  The study then compared relapses, or return of symptoms, in the two groups over time –  the pimavanserin group had a “highly statistically significant” longer time to relapse, indicating benefit.

This is a valuable step forward.  Delusional thoughts and hallucinations are unfortunately common among those with cognitive disorders, and add substantially to distress, care needs, and caregiver burden.  No medication is FDA-approved for treatment of psychosis in dementia, and current treatments are not highly effective and often come with side effects.

We will certainly look forward to seeing the details from this trial – the extent of benefit, potentially adverse effects, and the workings of the relapse-prevention study approach.

Importantly, these positive findings in a Phase 3 trial for Alzheimer’s disease and other dementias, uncommon lately, reinforce our quest to find better treatments.  They also show that an alternative medication class – a little outside the box – can have value.  Finally, they remind us that improving symptoms of these illnesses that currently afflict millions is a huge goal, along with strategies to prevent Alzheimer’s disease.

Dr. David Sultzer is a board-certified Geriatric Psychiatrist and Professor of Psychiatry & Human Behavior at UCI School of Medicine. After more than 20 years at UCLA and the West Los Angeles VA Hospital, Dr. Sultzer recently joined the team at UCI MIND and leads its clinical research operations, including clinical trials for new treatments. He is internationally recognized for his research activities to better understand the phenomenology, pathophysiology, and treatment of Alzheimer’s disease.