New drugs for Alzheimer’s trial
pharmafile | October 15, 2012 | News story | Research and Development, Sales and Marketing | Alzheimer's, Roche, lilly
Roche and Eli Lilly are providing drugs free of charge to US investigators conducting a worldwide trial of Alzheimer’s disease treatments next year.
The study is looking at three investigational compounds – two of which are from Lilly – designed to counter the effects of amyloid beta, the main ingredient of brain plaques found in Alzheimer’s patients, in different ways.
The trial will be run by the Dominantly Inherited Alzheimer’s Network (DIAN) Trials Unit at Washington University School of Medicine in St. Louis.
Researchers are supported by DIAN – a collaboration between various Alzheimer’s research centres – plus the Alzheimer’s Association and the DIAN Pharma Consortium, which comprises ten pharma firms.
These companies put forward more than a dozen drugs which might help the trial, from which three were chosen for testing:
- Roche’s Gantenerumab, an antibody that binds to all forms of aggregated amyloid beta and helps remove them from the brain – it is currently in the Phase III SCarlet RoAD trial
- Lilly’s Solanezumab, a Phase III monoclonal antibody which binds to soluble forms of amyloid beta after they are produced, allowing it to be cleared before it clumps together to form plaques
- Lilly’s beta-secretase (BACE) inhibitor, a Phase II small molecule, may also be included and is thought to work by reducing the amount of amyloid beta proteins produced, slowing the accumulation of plaques.
The new trial is supported by a $4.2 million grant from the Alzheimer’s Association while Roche and Lilly will also put in money as well as waiving the cost of their drugs.
The idea is to prevent the loss of cognitive function in patients: 160 people with inherited mutations that cause early-onset forms of the disease will be studied to identify whether the drugs can improve Alzheimer’s biomarkers.
All patients will be within 10 to 15 years of the age when symptoms of dementia tend to appear, which means they are likely to already demonstrate biological indicators showing the disease is beginning.
These indicators could include evidence of brain plaques and changes in the blood and cerebrospinal fluid.
Scientists will monitor them to see whether the new treatments slow or stop the disease process: the first part of the trial is scheduled to last two years, although it will be expanded and extended if one or more drugs proves effective.
The health of 80 DIAN participants who did not inherit the Alzheimer’s mutations will also be monitored.
“Normally in clinical trials there is a 50/50 chance of receiving the active drug or a placebo, but the efficient design of testing three drugs will allow us to significantly boost the number of participants who receive active treatments,” explained principal investigator Randall Bateman, professor in neurology at the St. Louis-based university.
Those with inherited forms of Alzheimer’s will be randomly assigned one of the three investigational drugs (giving them a 75% chance) or a placebo (25%). Those without mutations will receive a placebo.
Adam Hill
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