Talk:Aducanumab

CAS Number

The CAS Identifying number is a dead link; the substance is not found. Jed 20012 (talk) 00:42, 9 January 2014 (UTC)

Walled only. [1]~so OK. -DePiep (talk) 10:49, 26 October 2019 (UTC)

Here is the the critical valid science report

Alluded to in the article, and sourced at present only via the company's self-published press release:

"SCIENTIFIC PROGRAMME

Session T04 Treatment, Symposium 26: AMYLOID-REDUCING THERAPIES IN ALZHEIMER’S DISEASE. 20-Mar-2015 09:15 11:15

<redact>

Co-authors J. Sevigny1, P. Chiao1, L. Williams1, X. Miao1, J. O'Gorman1.

1Clinical Developement, Biogen Idec, Cambridge, USA."

[For online version, see [2].]

It is the poorest of form for there to be no reportable scientific information here. I am in favour of blanking out the results reported from the press release, as they cannot be traced to this, which is a valid scientific publication (conference abstract). It is up to the company to report the results in a way that they can be reviewed, and this abstract is devoid of any real content. (This is my field, and I understand why it is content-free. The point is that reporting on the matter at WP has to await another publication, and cannot be based on the company's press release.) Le Prof 71.201.62.200 (talk) 18:56, 8 June 2015 (UTC)

redacted COPYVIO. Jytdog (talk) 13:12, 1 July 2015 (UTC)

What were the high doses exactly? Are they already testing even higher doses?

Perhaps even higher dose would give better results?

Wikipedia now says:

In the first "EMERGE" trial (NCT02484547), an analysis split by dose indicated that high doses reduced rate of decline by 23% versus placebo. A second identical trial "ENGAGE" failed to replicate this, with a non-significant 2% reduction in decline compared to placebo.

--91.159.185.71 (talk) 15:04, 12 June 2021 (UTC)

Post-FDA Approval

The intro section, and probably the whole article, should be flagged and looked at by an expert. to see if the drug helps treat symptoms of Alzheimer's, really? The most significant thing about it is that it would be the first to treat the hypothesized root cause and NOT the symptoms.

It is wrong to say that Aducanumab is "is the first therapy that targets the fundamental pathophysiology of the disease," even if the press release says so. According to the New York Times (and other sources), there were several drugs that attacked amyloid; they all failed clinical trials. Amyloid is the hypothesized root cause, and experts disagree.

If you say that Aducanumab "treated" symptoms, it depends on how you define "treated," since it had no effect on symptoms. Members of the advisory committee kept emphasizing that the drug only reduced amyloid, a secondary endpoint, but had no clinically significant effect on the symptom of cognitive ability, which is the primary endoint. As Knopman said, it only improved biomarkers, without improving cognitive decline.

This issue of primary vs. secondary endpoints comes up regularly in the medical literature (eg Kesselheim). The drug companies regularly demonstrate improvements in secondary outcomes that have no measurable change in patient health. As an editorial decision, I think this is a central issue in the debate over the approval, and we should make it clear.

I think a careful reading of WP:RS and WP:MEDRS will show that we can use the NYT as a source, especially if there are no published trials, and especially if we're using a press release. If you can find a better WP:RS, let's see it.

https://www.nytimes.com/2021/06/10/health/aduhelm-fda-resign-alzheimers.html

Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.

By Pam Belluck and Rebecca Robbins

June 10, 2021

"The committee had found that the evidence did not convincingly show that Aduhelm could slow cognitive decline in people in the early stages of the disease..."

"...several respected experts, including some Alzheimer’s doctors who worked on the aducanumab clinical trials, have said the available evidence raised significant doubts about whether the drug is effective. They also said that even if it could slow cognitive decline in some patients, the suggested benefit — a slowing of symptoms for roughly four months over 18 months — might be barely noticeable to patients...

"Clinical trials of other amyloid-reducing drugs over more than two decades have failed to offer evidence that the medications slowed cognitive decline."

Knopman: “Biomarker justification for approval in the absence of consistent clinical benefit after 18 months of treatment is indefensible.”

--Nbauman (talk) 20:54, 11 June 2021 (UTC)

Adverse effects

From what I've read, the drug is NEITHER safe nor effective. I read that 20% of users had brain swelling!! This article needs a total rewrite. The lead reads like Biogen PR. The fact that the results of the clinical trial were poor and that the trial was halted due to "futility" is noteworthy. The fact that a post-trial reanalysis found some reason to hope that maybe it might have some benefit for some patients needs to be framed in the context that that. is. not. good. science. (post-hoc endpoint choice). Heck, I'm hopeful it will benefit some folks, but that's yet to be shown. It would be useful, imho, to mention if other nations have (independently) approved its use...are there any? And the approval itself was atypical and based on a fast-track process. Really, the article is not even a stub, imho. No discussion of Phase I/II trials? (Almost) No discussion of the aborted Phase III trial? really? No mention that 8 of the 9 members of the independents voted "No" and the last abstained (if that's the right word). That is, none of them believed it should be approved. No mention of whether or not they discussed fast-track approval? Also, while "monoclonal antibody" isn't wrong, why not include the fact that it's a four peptide glycoprotein (if I've got that right...) 98.21.217.178 (talk) 16:27, 2 July 2021 (UTC)

I globally agree whith your comments. Could you please mention ref of relevant articles from good sources which substantiate your statements? Reneza (talk) 12:54, 22 November 2022 (UTC)

Resignation

The resignation of 3 officials was from a committee, not from the FDA itself. May I correct the lede to reflect this better? 38.73.253.217 (talk) 13:13, 15 July 2021 (UTC)

Necessarily used with together with EPA and DHA Omega−3 fatty acids AND with B12 vitamin

We might target the beta-amyloid protein plaques, but they provide structural support. If we only REMOVE and not REPLACE we 1. cause the overall brain to internally collapse, 2. only removing the bad and not replacing with good (insulators and structural support) causes inflammation.

(Still for few people it doesn't work... but for others the boosted formula works.) - [ anon-ip - 22 August 2021‎ ]

Above seems inappropriate OR on this talk page - Can it be hidden/moved/deleted ? - Rod57 (talk) 11:55, 8 December 2021 (UTC)

Can we include details of the two clinical trials mentioned

Can we include details of the two clinical trials mentioned (EMERGE and ENGAGE) - eg patient numbers ? What are the differences in how they were carried out ? Has anyone written about why the results might be different ? If the two trials were or could be combined, would the combination result be statistically significant ? - Rod57 (talk) 12:00, 8 December 2021 (UTC)

Additional sources for improving the article

Please add refs that could help to improve the article

• 08 June 2021 Landmark Alzheimer’s drug approval confounds research community https://www.nature.com/articles/d41586-021-01546-2
• ......

Reneza (talk) 13:05, 22 November 2022 (UTC)

Needs cleanup

The sections on process concerns and economics/price are redundant in some places and contradictory in others. Suggest combining. Seananony (talk) 13:05, 5 May 2024 (UTC)