"When the brain is severely damaged with full-blown Alzheimer's disease, it's very hard to treat. There's already been a lot of damage and you can't replace the neurons that have died," said Kosik.
About two years ago, Kosik received a call to do this study from colleague Eric Reiman, executive director of the Banner Alzheimer's Institute in Phoenix and another lead researcher. At that time, several Phase 3 trials on what was hoped to be a viable treatment for sufferers of the disease had failed, forcing the neuroscientists to rethink their approach.
What is unique about this opportunity, said Kosik, is that the population being studied is a relatively homogenous group. Family members have the same genetic mutation, the same rural background, similar diets, and activities.
"They have said over and over that this disease has been such a burden to them, that they want to participate in a clinical trial," Kosik said.
The study involves testing candidates for the genetic mutation, taking a record of baseline conditions, administering either the medication or a placebo over a period of time, and monitoring the subjects' progress. In this double-blind trial, neither the subjects nor the investigators will know which subjects have the mutation, or which ones receive the drug or the placebo. A third party will handle that information.
Additionally, a group of participants that don't have the mutation will be included in the mix, and will receive the placebo a measure taken to ensure that the family members in the study don't know whether or not they have the mutation. In total, 300 members of the family will be participating in the first phase of the study.
Kosik, who has been concentrating on the genetic and ethical side of the research, said he agonized over whether the family members should be told of their genetic status.
"It's very dangerous knowledge," said
|Contact: Sonia Fernandez|
University of California - Santa Barbara