Relieve the mental symptoms of Alzheimer's disease, the new drug phase 2 results are significant

Relieve the mental symptoms of Alzheimer's disease, the new drug phase 2 results are significant

February 27, 2018 Source: WuXi PharmaTech

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Recently, a double-blind, single-center, phase 2 clinical trial of pimavanserin in the treatment of psychotic symptoms in patients with Alzheimer's disease was published in the March issue of Lancet Neurology, the University of Exeter Medical School. Led by Dr. Clive Ballard of the University of Exeter Medical School.

About 8 million people in the United States suffer from dementia, and about 5.5 million of them suffer from Alzheimer's disease. Studies have shown that about 30% of people with dementia suffer from mental illness, usually including hallucinations and delusions. Dementia-related psychoses include Alzheimer's disease psychosis, Louis's dementia, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. The consequences of the disease are related to the severity or persistence of mental illness in dementia patients, such as repeated hospital admissions, premature admission to nursing home care, rapid progression of dementia, increased morbidity and mortality. This group still has huge medical needs that are not being met.

Pimavanserin is a selective serotonin inverse agonist (SSIA) that preferentially targets the 5-HT2A receptor, which plays an important role in dementia-associated psychosis. Currently, Pimavanserin is being evaluated in a wide range of clinical projects involving multiple indications. In 2016, the FDA approved Pimavanserin (NUPLAZID®) for the treatment of hallucinations and delusions associated with Parkinson's disease, the first drug to be used for this indication.

▲Pimavanserin's molecular structure (Source: Wikipedia)

The second phase of the study, a double-blind, placebo-controlled trial, enrolled 181 patients with Alzheimer's disease who developed delusions, hallucinations, or both. They were assigned to receive 12-week pimavanserin or placebo treatment, and then assessed for symptoms on the Nursing Home Edition (NPI-NH) Neuropsychiatric Scale at weeks 2, 4, 6, 9 and 12 after dosing. The primary endpoint was NPI-NH change from baseline to week 6, with lower scores indicating fewer symptoms.

The results of this study were presented at the Conference on Clinical Trials of Alzheimer's Disease (CTAD) held last year. The results showed that at week 6, the NPI-NH score of the treatment group decreased by 39.5%, which was significantly higher than that of the placebo group of 19.3%, reaching the primary end point of the study. Moreover, no damage was observed to the patient's cimavanserin.

“In the Phase 2 study, pimavanserin significantly reduced mental illness in patients with Alzheimer's disease, but did not have a negative impact on cognition,” said Dr. Clive Ballard, Vice President and Executive Dean of the University of Exeter Medical School: “With Pimavanserin also has good tolerability characteristics compared to the known side effects of current antipsychotic drugs. There are significant unmet needs in this area due to the lack of approved treatment for dementia-related psychosis. It shows that pimavanserin may become an important new treatment for this unmet old population."

We expect this new drug to effectively relieve the symptoms of mental illness in people with dementia.

Reference materials:

[1] Pimavanserin Phase 2 Trial Data Published

[2] ACADIA Pharmaceuticals Presents Data from the Phase II Study of Pimavanserin in Alzheimer's Disease Psychosis at the Clinical Trials on Alzheimer's Disease (CTAD) 2017 Meeting