Dr. Stephen Salloway heads the neurology department and Memory and Aging Program at Butler Hospital, where, as part of a study, some patients have been taking an investigational drug for Alzheimer’s disease since 2013. Biogen, the maker of the drug, halted further research at one point but reversed course and recently announced that it will seek a review from the Food and Drug Administration early next year.
Salloway discusses what impact further testing, and possibly FDA approval, of aducanumab could mean for Alzheimer’s patients.
PBN: What involvement have you and Butler’s Memory and Aging Program had with Biogen’s investigational drug aducanumab?
SALLOWAY: The Memory and Aging Program began testing aducanumab in the PRIME trial in 2013. We saw promising early results, which were reported at the time in the journal Nature. Two large confirmatory trials to evaluate the efficacy of aducanumab began in 2015 – one called ENGAGE and one called EMERGE. I am the global co-chair of the Investigator Steering Committee for both of these studies, and the Memory and Aging Program is one of 67 research sites across North America taking part in the ENGAGE study. We had 60 patients taking the medication as part of that study.
PBN: Were you aware that Biogen intended to stop its studies on aducanumab? What was your reaction when the company announced its intentions to seek an FDA review of the drug early next year?
SALLOWAY: Yes. Biogen halted both the ENGAGE and EMERGE trials last March, when initial data suggested that the drug would likely not reach the benchmarks necessary to be considered an effective treatment. It was a shocking and crushing blow to our research team here at the Memory and Aging Program, but especially to our patients participating in the study. We had been seeing positive results from the drug in many of our participants, so to find out that the initial data wasn’t bearing that out on a larger scale was very surprising, and to say that it was disappointing is an understatement.
The recent announcement that additional data is now showing that aducanumab actually does have a significant effect in slowing the progression of Alzheimer’s is an absolute game-changer.
As additional data was collected, it became clear that drug is much more effective when given at higher doses, and that is what has made the difference. These findings are much more in line with the results we were seeing here at our program, and for our patients. We couldn’t be more thrilled. Researchers had long held high hopes that aducanumab would be the first drug to offer a breakthrough treatment that could actually slow or even halt Alzheimer’s, and now it looks as though those hopes may be fulfilled.
PBN: Will patients who were participants in the research trial at Butler now be able to continue taking aducanumab?
SALLOWAY: All of our patients who were participants in the ENGAGE or PRIME trials will have the opportunity to resume taking aducanumab as part of a new re-dosing study, provided they also meet this new study’s requirements. The re-dosing study will reevaluate the efficacy of the drug when given exclusively at high doses. This is such wonderful news for our patients – potentially life-changing – and we’re so happy for them.
PBN: If it is approved, how much of an impact could aducanumab have on patients diagnosed with Alzheimer’s?
SALLOWAY: This would be the first drug approved to treat Alzheimer’s disease in 16 years and the first to target removal of amyloid plaques. In short, it could be life-changing for thousands of people who are now living with early-stage Alzheimer’s, as well as those who are diagnosed with it in the future. It will offer patients the opportunity to slow the progression of the disease and maintain quality of life for longer, potentially even halting its progression altogether.
This is also why early detection is so important, as well as the research studies we have going on right now that are looking at ways to diagnose or predict the development of Alzheimer’s before significant symptoms even develop. If we can do that, and then use this drug to slow progression as early as possible, it could drastically change the outlook for those with Alzheimer’s disease.
PBN: Is the Memory and Aging Program involved with any other investigative Alzheimer’s treatments that appear promising?
SALLOWAY: Yes, we have multiple studies ongoing. Some are aimed at treatment and some are focused on developing methods for early detection. We are testing immune-based treatments to remove both amyloid plaques and tau tangles. We are also developing new brain scans to safely detect tau tangles and new retinal imaging techniques to measure the first changes in the eyes to detect the risk for Alzheimer’s disease. Soon, we hope to launch new trials involving exercise and diet to prevent Alzheimer’s disease.
In order for our studies to happen, we of course need participants. That’s why we’ve been putting the word out for people ages 40 to 85 to join our Alzheimer’s Prevention Registry at Butler Hospital. You don’t need to have Alzheimer’s disease or any cognitive dysfunction at all to join, and you can join in just a few minutes on our website at butler.org/ALZregistry. We use the registry to match people up with ongoing or future studies for which they may qualify. If it looks like you may be a good match, our team will get in touch and offer the opportunity to participate – but you’re never required to participate.
Elizabeth Graham is a PBN staff writer. She can be reached at graham@pbn.com.
