Potential Alzheimer’s Treatment, Now in Phase 3 Testing, Gets Boost from FDA
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Aducanumab, an amyloid-fighting medication being developed by Biogen for Alzheimer’s disease (AD), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The treatment is currently being evaluated in two large-scale Phase 3 trials, both of which are recruiting Alzheimer’s patients.
The FDA’s fast track program allows for faster approval of medications for serious conditions that are not adequately treated, such as AD.
“By collaborating with regulators through programs like Fast Track, we hope to bring effective treatments to patients and families affected by Alzheimer’s disease as quickly as possible,” Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, said in a press release.
Aducanumab is thought to block beta-amyloid from sticking together in what are known as plaques, stopping the toxic protein from forming cell-killing deposits in the brains of people with AD. Based on animal studies and initial brain imaging data in humans, aducanumab seems to reduce amyloid plaques.
Two global studies, ENGAGE (NCT02477800) and EMERGE (NCT02484547), are now in progress. The trials are evaluating the safety and effectiveness of aducanumab in delaying cognitive impairment and disability in people with early AD. Anyone interested in learning more about these Phase 3 trials — taking place across the U.S., Canada, Europe and elsewhere — can do so through this website provided by Biogen, or by clicking on the identifying numbers given above for each study.
Biogen also released information about an earlier study, called PRIME. This ongoing Phase 1b study is focusing on the safety, tolerability, drug activity in the body, and clinical effects of aducanumab in patients with probable or mild AD.
A research report based on the trial, “The antibody aducanumab reduces Abeta plaques in Alzheimer’s disease,” was recently published in the journal Nature.
In the study, participants were given either placebo or aducanumab at 1, 3, 6 and 10 mg/kg. The drug induced improvements in clinical measurements of cognition and memory, and brain amyloid plaques decreased and were almost completely gone in the group that received the highest dose of the medication.
PRIME also includes an extension, after the study’s one year, offered to those patients given placebo.
According to Biogen, data from PRIME support the study design of the ENGAGE and EMERGE studies. Biogen plans to release additional information about PRIME at upcoming medical conferences.
Biogen developed aducanumab (BIIB037) for the treatment of early AD. It is a human recombinant monoclonal antibody identified based on known information about B-cells (immune system cells) that were collected from healthy elderly people. The company collaborated with Neurimmune, using technology called Reverse Translational Medicine. Biogen licensed aducanumab from Neurimmune as part of a collaborative agreement.
Kathy Nicholsen
I currently take Aricept 10 mg. Treated for over 10 years for MCI, heard about new drug tests for Aducanumab, hoping to try this, please, I am a 64 year old white female.
Lori
I was in a drug study when I was in my 30's taking Aricept for help with migraines. It was extended another year so I did it the entire time. It not only got rid of my migraines so far for good but my mind was so clear and sharp as well as my memory. It was wonderful and I still say people should start getting it earlier for prevention. I am 62.
Gary T
Would this drug help people with leuwey body dementia?
Tim Bossie
Hi Gary. We do not have enough information about this trial right now to say yes or no. You can ask your doctor about this or stay tuned when we have more information.
Elena, from NYC
I know of too many people who are dealing with AD, including my mother; its a devastating condition. I can't wait to see this medication approved.
Tim Bossie
We are sorry to hear that your mother suffers with this terrible disease. As with you, we also hope that someday there is a medication that can really help.
Miguel Carlos
Could someone please tell me why Biogen wouldn't be involving patients with severe AD in their clinical trials?? I get it that the biotech industry needs to be very careful in who they enroll because of how litigenous this world has become but people and families are suffering.
marilyn moran
I think that once AD gets to a certain point, no medications would work. It is important to catch at the very beginning. Once a disease progresses its unlikely that drugs can work unless they are a miracle drug and sometimes it does happen.
Daniele Demos
Hi there
My mother was diagnosed with CBD (Cortico Basal Degeneration) in 2014 and was almost included in phase 2 of the Clinical Trial for Epothilone D a few years ago. I was wondering if you have any idea when this medication would be available to purchase. Thank you very much, Daniele
Tim Bossie
Hi Daniele, we are sorry to hear about your mother and her battle with this disease. We wish we could give you a definite answer, but unfortunately we do not know of any time table regarding this med. However, we are keeping our ears and eyes open to any new news and will report as soon as we know.
Daniele
Hi again
Thank you for your kindly response.
Daniele
Patrick
Please tell me where I can get this medication
Marty Kinrose
I would like to volunteer for an aducanumab trial
with Biogen.
My mother had Alzheimer's for 8 years before she died. My DNA seems to be closely aligned with hers and my mental capacity has diminished noticeably in the past 3 years. I don't want to go out like my mother. Please let me know who to contact regarding participation in a trial of this drug.
Elly
My husband and I just signed up for the Phase 3 study. We really like to keep informed about any progress on this medicine.
Mac
I thought this study failed or I must be confusing it with another announcement.
Harold Wohl
My wife was diagnosed with AD when she had a shunt put in about 2.5 years ago for hydrocephalus. However, I believe she may have frontotemporal dementia (based on a comparison of the effects of each (AD and FTD). Are either of these two studies made for someone who 1. May not have early AD but more advanced AD (if that be her case) or 2.Has FTD, if that be her case?
Erik Hörnell
My wife participated in the EMERGE study and got very serious side effects with a big swelling in the brain. She got very bad and it took two months after ending the medication before she recovered reasonably. Had we known about these side effects we would not have participated in the study.
Michele Asmar
My mother is presently on phase 3 trial ... Erik Hornell can you please share more about your wife's side effects during her trial...I am concerned about some of the changes in my mom. thanks
Mike Wood
I am involved in the Phase 3 study (Vancouver, British Columbia Canada) and so looking forward to finding some answers to my memory issues. Only 53 so if there is a diagnosis, hoping early intervention helps. So many sad stories of those with advanced stages of AD.
harry
The confusion and uncertainty of AZ and LBD diagnosis is frustrating,if symptoms of both appear,the trial for the efficacy of Aducanumab appears to eliminate the patient,,my wife is in that predicament,,any chance of getting a successful treatment is eliminated,so the pain of watching some die as they live on is mind boggling.
SoCal Gal
How does one get to participate in this or other "clinical trials?"
Rachel
Hello my husband mother is in an early stage at moment on Aricept 2weeks in but getting complications from taking it. How do we get her in for consideration for phase 3 trial of Aducanumab? Thank you