Cedars-Sinai launches Phase I clinical trial to study tolerability of immunization to treat Alzheimer's disease

Cedars-Sinai Medical Center has launched a Phase I clinical trial to study the safety and tolerability of an experimental immunization to treat Alzheimer's disease. The treatment is based on Copaxone^® (glatiramer acetate), a drug often prescribed to reduce the frequency of multiple sclerosis relapses.

"In mouse models of Alzheimer's, immune-modulation with Copaxone appeared to stimulate key immune cells, reduce harmful inflammation, clear toxic plaques and support the restoration of neurons in a region of the brain that is responsible for learning and memory. We're now translating these findings into human studies and this first trial will evaluate the medication's safety and tolerability in patients suffering from Alzheimer's," said Patrick D. Lyden, MD, chair of the Department of Neurology and the trial's principal investigator.

After a battery of tests, including detailed brain imaging and a spinal tap, patients will receive Copaxone shots weekly. Tests will be repeated three months later to determine if the drug caused any changes in the patient's memory or brain function, said Lyden, the Carmen and Louis Warschaw Chair in Neurology.

These studies result from a new way of thinking about inflammation in the central nervous system, according to Maya Koronyo-Hamaoui, PhD, assistant professor of Neurosurgery and Biomedical Sciences, who conducted the preclinical studies at the Maxine Dunitz Neurosurgical Institute, in collaboration with Keith L. Black, MD, professor and chair of the Department of Neurosurgery, director of the neurosurgical institute and the Ruth and Lawrence Harvey Chair in Neuroscience.

Scientists used to believe that all inflammation in the brain and spinal cord was damaging and looked for ways to suppress immune activity. But recent studies have shown that some immune responses are beneficial, especially after injury. The new idea is to enhance recruitment of immune cells from the blood to the brain to fight the disease, regulating detrimental inflammation and supporting tissue repair and regeneration, the researchers said.

In the preclinical studies, Copaxone appeared to accomplish these tasks and protect mice against the cognitive deficits of Alzheimer's by also boosting a gene (EGR1) that modulates other genes that are important for the survival and recovery of nerve cells in the brain.

Source: Cedars-Sinai Medical Center