(RxWiki News) The number of people with Alzheimer's Disease (AD) is expected to rise. There are no treatments to prevent AD. A trial is planned to see if drugs may be able to stop the onset of AD.
Drug companies, Alzheimer’s groups and researchers will be working together to start the trial in early 2013. Drugs will be tested in people at risk for early-onset AD.
It will be years before any results come out of the trial. But, this trial should provide information which may lead to prevention strategies.
"Talk to a doctor about your risk for Alzheimer’s."
Researchers at the Washington University School of Medicine in St. Louis working with pharmaceutical companies and patient advocacy groups have announced the drugs they hope to use in the coming trial.
The trial will be run by the Dominantly Inherited Alzheimer's Network Trials Unit (DIAN). DIAN is a group of AD research centers funded by the National Institutes of Health.
A total of 160 people who have the gene for early-onset AD will be enrolled in the trial.
People with early-onset AD develop symptoms as young as their 40’s. It is less common than late-onset AD, which typically begins when a person is over 65.
Early-onset AD has a known genetic link. People with this gene are very likely to develop symptoms of AD in middle age.
The trial is looking to see if drugs can slow or stop the onset of AD for people who have high risk for early-onset AD.
Three different drugs are proposed. Each has a different way of going after beta amyloid.
In all forms of AD, beta amyloid builds up in the brain to form plaques. These plaques are thought to interfere with brain function – causing memory and thinking problems.
One of the drugs, gantenerumab, attacks beta amyloid deposits in brain. It will be supplied by Roche Pharmaceuticals.
Another drug, solanezumab, works to clear beta amyloid before it becomes part of plaques. It will be supplied by Eli Lilly.
A third option that is in Phase II trials may be included. It is a beta-secretase (BACE) inhibitor made by Eli Lilly. It is thought to lower the amount of beta amyloid produced by the body.
All three drugs are designed to slow or stop the build-up of beta amyloid plaques in the brain.
Roche and Eli Lilly are giving grant money to the investigators in addition to supplying the drugs.
The study will also be funded by $4.2 million grant from the Alzheimer's Association. Investigators have also applied for funding from the National Institutes of Health.
People with genetic risk will get one of the three drugs or a placebo pill. The trial will also track the health of 80 people who do not have the gene who will take a placebo pill.
dailyRx News spoke with Carla Perissinotto, MD, a geriatric specialist about this upcoming trial.
She said, "So this is really exciting. We have no treatments currently to prevent Alzheimers, i.e. we have no therapeutic primary prevention options. So if this works it would be revolutionary."
She went on to say, "Right now, we don’t know the exact correlation between the biomarkers and clinical symptoms. For example, we know having more amyloid-beta plaques usually correlates with more severe Dementia, but we don’t know what the threshold is."
"So, what will be even more important is to see if these medications lead to complete prevention."
People will start the trial 10 to 15 years before symptoms would be expected.
They will be tracked for 2 years, initially, to see if the drugs do anything to the build-up of plaques, which can start up to 10 years before symptoms show up.
If any of the drugs seem promising, the researchers hope to extend the study for longer.
Washington University announced this collaborative effort on October 10.
The DIAN Trials Unit has launched an expanded registry. For more information or to register for potential participation in the trial, go to http://www.DIANXR.org or call 1-800-747-2979.
