An international group of experts is calling for new approaches to clinical trials that focus on the neuropsychiatric symptoms of Alzheimer’s, including psychosis, agitation, apathy, depression, and sleep disturbances. Their aim is to facilitate a better understanding of the underlying mechanisms of these symptoms in order to foster new and effective treatments.

“We have been stuck in this damaging cycle of prescribing antipsychotics for people with dementia, despite the fact that there are minimal benefits and lots of harms as a result,” said lead author Dr. Clive Ballard, professor of age-related diseases at the University of Exeter Medical School in the United Kingdom.

“We now urgently need new drugs and new non-drug interventions, so we can improve treatment of these distressing symptoms to millions of people worldwide.”

Although up to two-thirds of patients with Alzheimer’s disease experience psychosis, it still remains a widely under-recognized symptom and one that is extremely difficult to treat.

Typical antipsychotic treatments have little impact on alleviating Alzheimer’s psychosis and sometimes lead to devastating side effects, resulting in 1,660 unnecessary strokes and 1,800 unnecessary deaths in the U.K. every year. In addition, psychotic symptoms are linked to faster cognitive and functional decline and accelerated death rates.

In other types of dementias, such as Parkinson’s disease dementia and Lewy Body dementia, both the symptoms of psychosis and the side effects of treatments are even more extreme: In these diseases, commonly prescribed antipsychotic medications quadruple the risk of stroke and death.

The group of experts was convened through the Alzheimer’s Association Research Roundtable, an ongoing effort that brings together experts in the field from academia, industry and government to address ways to overcome barriers to drug development.

Ballard said new treatments that work in a different way than current antipsychotics are yielding promising results in relieving symptoms without adverse outcomes. But outcome measures need to be standardized to ensure they are meaningful to both clinicians and people with dementia and their caregivers.

“At Exeter we are already developing specific psychological therapies, running clinical trials of novel drug approaches and using-cutting edge genetic techniques to identify new targets for safe and effective therapies and to allow us to use current treatments in a more focused way,” he said.

Psychosis and other neuropsychiatric symptoms are often among the first signs of dementia, yet often are not recognized as warning signs. These symptoms lead to substantial distress for both people with dementia and their caregivers, and contribute to patients moving into residential care earlier, placing financial burden on the social care system.

The paper is published in the journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

Source: University of Exeter