#AAN2018 – PRIME Trial Data Show Long-term Benefits of Aducanumab in Early Alzheimer’s
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Long-term use of BIIB037 (aducanumab) can prevent progression of Alzheimer’s in patients at early stages of the disease, according to results from the PRIME study.
Biogen, maker of aducanumab, will present those results at the 2018 Annual Meeting of the American Academy of Neurology (AAN), April 21-27 in Los Angeles, California.
The clinical effects of 24 and 36 months treatment with aducanumab will be presented in two studies, “Aducanumab titration dosing regimen: 24-month analysis from PRIME, a randomized, double-blind, placebo-controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease” and “Aducanumab 36-month data from PRIME: a randomized, double-blind, placebo- controlled Phase 1b study in patients with prodromal or mild Alzheimer’s disease.”
The PRIME trial (NCT01677572) is an ongoing Phase 1b study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics (i.e., the interactions between the body and a compound) of aducanumab in 197 participants, aged 50-90, who had clinical manifestations consistent with prodromal (early) or mild Alzheimer’s disease.
Patients were randomized to receive 3, 6, or 10 mg/kg fixed or adjusted doses of either aducanumab or placebo.
Both patients treated with fixed or adjusted doses of aducanumab had a significant reduction in the levels of amyloid plaques in the brain – the hallmark of Alzheimer’s disease.
This reduction also was observed in patients who initially were in the placebo group and later switched to aducanumab. Importantly, patients treated with the highest dose for up to 36 months achieved amyloid plaque reductions to levels below the point that allows their detection in scans.
Positive data concerning patients’ cognitive and physical function, determined by the Clinical Dementia Rating sum of boxes (CDR-SB) and the Mini-Mental State Examination (MMSE) tests, also suggested benefit of long-term use of aducanumab.
No new cases of brain swallowing due to amyloid-related abnormalities (ARIA-E) were reported in patients treated with a fixed dose of the investigative drug, during 24 and 36 months of follow-up. Also, only four patients experienced more than one ARIA-E episode during the initial 24 months.
Collectively, these results support further development of aducanumab in more clinical trials.
Biogen is currently recruiting participants for its two Phase 3 trials, ENGAGE (NCT02477800) and EMERGE (NCT02484547), evaluating the effectiveness and safety of aducanumab in early Alzheimer’s disease.
Daniel R Bryson
All of these clinical tests are run using only candidates with early detection of Alzheimers. Why aren't any of the "trials" run on candidates, that have been patients for 3, 4 or 5 years and can not pass the written tests, to see if these clinical trials will give others some hope and optimism to them and their family. I have repeatedly asked and asked if there is a place/research center running these trials and I get no help! Have the researchers, investors and government given up on all of these candidates. Wouldn't it make sense if a person that has advanced dementia had favorable reaction to one of these drugs that it would indicate the possibilities of IT being a start towards the cure??? Will travel to participate in one of these trials!
Jeff. Rader
To: Dan Bryson, You would need a referral from your primary care physician to go. You can try Department of Neurology Memory Disorders Clinic Ohio State University in Columbus, Ohio 43210, Phone: 614-293-4969.
Sonia Tarantino
I agree that these memorie tests exclude some good candidates for studies that could benefit from these trials.
DANTE MARCIANI
The results of aducanumab are a good proof that a preventive AD vaccine intelligently designed would be an effective way to prevent or delay the onset of AD. I said "intelligently" because all the past vaccines were designed to fail, but with the hope that they will work. Because of the neurodegenerative nature of AD, it is near to impossible to honestly talk about a cure for advanced cases. Yet, preventing or delaying the onset of AD, would be welcomed news for society.
PTM
When is old, too old to yield important results in the trials? I am the guardian of a 94 year old. She practiced child psychotherapy into her 90s. When dementia hit her, she was 91 years old and was still practicing part-time. Dementia hit her fast and hard, yet she retained her intelligence--just not her memory. She still has fairly accurate reasoning, can follow conversations, even discusses psychology theory and solves some of the problems of her nurses. She just can't remember if she ate, how to get dressed and what she talked about five minutes after a conversation ends. She is physically healthy and could still have many years left (relatively speaking). I would love information on the trials and if even, at her advanced age and stage of dementia if she might not be a candidate who could yield some valuable information in the drug trials. The real Dr. B would love being part of a breakthrough of this kind.
james
The Biogen company announced in Feb/2018 the current BIIB037 (aducanumab)phase 3 result was not expected as their original assumption based on phase 2 result. The company added 500 more sample size patients and expect the result in 2020.
It is confusing to see here to have the breakthrough in less 2 months to have this conference in April ?
https://www.bloomberg.com/news/articles/2018-02-14/biogen-drops-after-alzheimer-s-drug-trial-change-raises-concerns
ed fazekas
has there been any improvement for those receiving the drug??? It seems to me if an individual has this disease,that what has a person to loose by taking the medication.
Dorothy Knapke
i agree with ed fazekas. My husband has AD. Diagnosed 4 years ago. his symptoms have accellerated past 6 months. what would it hurt to try it now while he remains functional?