New drug trial will focus on people at risk of early-onset Alzheimer's disease
Wednesday 16 May 2012
A new clinical trial will test the drug crenezumab on 300 people who are cognitively normal but at very high risk of developing early-onset Alzheimer's disease.
The trial will begin in 2013 and will run for five years. According to Dr. Eric Reiman, executive director of Banner Alzheimer's Institute and co-leader of the project, tests may already indicate whether the drug helps delay memory decline or brain changes within two years.
Most of the trial participants will come from a large extended family of 5,000 people who live in Medellín, Colombia. Many of these family members carry a specific mutation of the presenilin-1 (PSEN1) protein. PSEN1 is known to be active in the development of Alzheimer's disease type 3 (AD3). Carriers often suffer the first signs of cognitive impairment around age 45 and many of them advance to dementia. The trial will include participants as young as 30.
During the study, 100 people will receive Crenezumab every two weeks and another 100 will receive a placebo. The researchers will take regular physiological measurements from PET and MRI scans and CSF tests. They will also administer memory and cognitive tests and will monitor changes in people’s emotional state.
Crenezumab is a humanized monoclonal antibody developed by Swiss-based AC Immune and licensed to Roche's Genentech. It is already being tested in two Phase 2 trials (see links below). The current trial is among the first projects in the new American Alzheimer plan. It will be funded for up to USD 100 million by Banner Alzheimer's Institute, Genentech and the National Institute of Health.