July 14, 2013
/PRNewswire-USNewswire/ -- Results of four research trials investigating new targets for therapies in Alzheimer's disease, and incorporating novel approaches to participant identification and selection, were reported today at the Alzheimer's Association International Conference® 2013 (AAIC® 2013) in
The trials involve four compounds that target physical changes in the brain associated with the development and progression of Alzheimer's disease. Two drugs are intended to reduce brain inflammation, one is thought to inhibit the production of an abnormal protein in the brain known as beta-amyloid, and the fourth promotes brain cell regeneration.
"The Alzheimer's disease epidemic is here. It is vital that we accelerate the pursuit of novel ideas and strategies to treat and prevent Alzheimer's disease," said
. Ph.D. Alzheimer's Association vice president of medical and scientific relations. "While many of the trials reported at AAIC 2013 are still in early stages, they represent a promising diversification of the Alzheimer's treatment pipeline and translate to new hope for a world without Alzheimer's disease in the future."
Microglial Modulator Reduces Inflammation and Improves Cognition in People with MCI
Inflammation in the brain has been implicated in the process and progression of Alzheimer's disease. Microglia are cells that act as the first and main form of active immune defense in the brain and spinal cord where they must react quickly to decrease inflammation and protect sensitive tissues. It has been recently suggested that amyloid plaques in the brains of people with Alzheimer's can stimulate microglia to produce compounds that cause brain cell damage. Thus, microglia have become a novel target for Alzheimer's disease therapies.
(Chiesi Pharmaceuticals Inc., Parma,
) is a microglial modulator that, in preliminary studies, has been shown to prevent brain plaque deposition and reduce deficits in transgenic mouse models of Alzheimer's disease.
At AAIC 2013,
, M.D., FACP, AGSF, CMD, CPI, of the Memory Enhancement Center of America, and colleagues at Chiesi Pharmaceuticals reported the results of a 90-week (14-weeks double-blind, placebo-controlled study followed by a 76-week open label extension study) trial of
at three different doses (200, 400 and 600 mg/day) in people with mild cognitive impairment (MCI). Participants received the same dose of the drug throughout the trial and were monitored for vital signs, cardiac activity, neuropsychological performance and safety.
Seventy-four (74) patients entered the open label part of the study: 26, 21 and 27 in the 200, 400 and 600 mg/day cohorts, respectively. At Study Week 40, 14 patients dropped out: four, two and eight in the 200, 400 and 600 mg/day cohorts, respectively. Three of dropouts were for adverse events: two in the 600 mg/day group (serum creatinine elevation and worsening of cognitive function) and one in the 400 mg/day group (pneumonia). The most frequent treatment-emergent adverse events were gastrointestinal disorders, with diarrhea being reported by 1.4 percent of patients on 200 mg/day, 6.3 percent of patients on 400 mg/day and 16.0 percent of patients on 600 mg/day.