Alzheimer Vaccine Trials Suffer Setback

Clinical trials on the Alzheimer's disease vaccine AN-1792 have been temporarily suspended after four of the 97 study participants in France developed inflammation of the central nervous system.

AN-1792 has been considered a potential breakthrough vaccine for the treatment of mild to moderate Alzheimer's disease after laboratory studies on mice showed it could clear out the plaques in the brain that are viewed as a cause of the disease. The vaccine spurs the body's immune system into destroying the build up of the plaques.

To date, approximately 360 study participants have been given the vaccine, including the 97 in France.

"The well-being of patients is always our paramount concern. Our decision to temporarily suspend further dosing, pending the results of our evaluation, is a standard approach to protect the safety of patients in clinical trials," said Dr. Ivan Lieberburg, Elan Corporation's Chief Scientific and Medical Officer. "A decision will be made on resumption of dosing pending the outcome of this investigation."

The drug companies said they will consult with an independent safety monitoring committee, study physicians and regulatory authorities before the vaccine is put back into use.

In Phase 1 safety studies, AN-1792 was given to more than 80 patients with mild to moderate Alzheimer's disease in a variety of dosages. The results from the U.S. single dose trial and the U.K. multiple dose trial showed that AN-1792 was well tolerated and that some of the patients developed an immunological response to the vaccine.

The results of the Phase IIa study are expected to provide additional information regarding the immune response to AN-1792.

Other sources: Elan Corporation