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January 27, 2020

Important Lewy Body Dementia Clinical Trial

by Guest Author

Pacific Neuroscience Institute offers final enrollment into important clinical trial for patients with Lewy body dementia. Find out more about this study and eligibility criteria.

SANTA MONICA  — Patients with Lewy body dementia may be eligible for a study of a treatment that was found to be effective in Alzheimer’s disease, according to results of ongoing studies.

Pacific Neuroscience Institute, which is affiliated with Providence Saint John’s Health Center, is leading a clinical trial for patients diagnosed with mild to moderate dementia associated with dementia with Lewy bodies (DLB, also called Lewy body dementia), a disease that includes neurological symptoms similar to Parkinson’s disease. DLB patients live an average of seven years after diagnosis. As there are no approved treatments for this condition, patients are often given drugs for Parkinson’s, but the treatment is not as effective.

Dr. Santosh Kesari and Dr. Melita Petrossian

Santosh Kesari, MD, PhD, principal investigator and director of Pacific Neuroscience Research Center, and Melita Petrossian, MD, director of the Pacific Movement Disorders Center, are leading the 21-week phase 2 double-blind trial testing a drug called neflamapimod on patients suffering with DLB. Early studies found that patients with Alzheimer’s disease and rheumatoid arthritis experienced improvements in response and memory while taking neflamapimod.

“We are very pleased to offer this opportunity for patients to enroll in a clinical trial aiming to improve cognitive outcomes in dementia with Lewy bodies,” said Dr. Petrossian. “Because the study drug might reduce inflammation in the brain and allow for increased formation of the connections between brain cells, there is good reason to hope this drug will not only improve clinical cognitive function but also change the course of the condition.”

In November, the Food and Drug Administration granted fast-track designation to investigation of neflamapimod treatment for DLB. The multi-center trial, already underway at Pacific Neuroscience Institute since September, is currently enrolling patients in Santa Monica, other sites in the United States, and two sites in the Netherlands.

“Patients with dementia with Lewy bodies face a very challenging condition with cognitive and behavioral changes as well as movement abnormalities, symptoms similar to those of Parkinson’s disease and imbalance,” Dr. Petrossian noted. “To date, management of these symptoms has been limited because there are no treatments approved for the disease. As a result, cholinesterase inhibitors such as donepezil and rivastigmine often are used even though they are not yet approved.”

A specialized research team from the Pacific Brain Health Center administers a series of questionnaire assessments to monitor any change in symptoms and function of enrolled patients. The trial is sponsored by EIP Pharma.

Trial Enrollment

The DLB clinical trial is open to those with a probable diagnosis of dementia with Lewy bodies, who are 55 years or older and who have been receiving cholinesterase inhibitor medications for at least three months. Patients will receive neflamapimod orally two to three times daily for 16 weeks, and possibly longer.

*** Update 02/16/21: The phase 2 trial was a success and has ended. We will update our information when we hear about the upcoming Phase 3 trial.***

Last updated: March 10th, 2021