Potential Alzheimer’s Treatment, Now in Phase 3 Testing, Gets Boost from FDA

Potential Alzheimer’s Treatment, Now in Phase 3 Testing, Gets Boost from FDA
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
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  1. Kathy Nicholsen says:

    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 says:

      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.

    • Tim Bossie says:

      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.

  2. Elena, from NYC says:

    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 says:

      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.

  3. Miguel Carlos says:

    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.

    • 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.

  4. Daniele Demos says:

    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 says:

      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.

  5. Marty Kinrose says:

    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.

  6. Elly says:

    My husband and I just signed up for the Phase 3 study. We really like to keep informed about any progress on this medicine.

  7. Harold Wohl says:

    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?

  8. Erik Hörnell says:

    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 says:

      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

  9. Mike Wood says:

    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.

  10. harry says:

    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.

  11. Rachel says:

    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

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