Deans' stroke musings: Representativeness of Participants Eligible to Be Enrolled in Clinical Trials of Aducanumab for Alzheimer Disease Compared With Medicare Beneficiaries With Alzheimer Disease and Mild Cognitive Impairment

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Tuesday, September 14, 2021

Representativeness of Participants Eligible to Be Enrolled in Clinical Trials of Aducanumab for Alzheimer Disease Compared With Medicare Beneficiaries With Alzheimer Disease and Mild Cognitive Impairment

From an analysis:

About 90% of people with Alzheimer's disease or mild cognitive impairment had at least one condition -- like cardiovascular disease, prior stroke, blood thinner use, chronic kidney disease, or age over 85 -- that would have excluded them from aducanumab (Aduhelm) clinical trials, an analysis of Medicare data found.

With the possible side effects I will never take something like this. Hopefully I'm still cognizant enough to object.

Representativeness of Participants Eligible to Be Enrolled in Clinical Trials of Aducanumab for Alzheimer Disease Compared With Medicare Beneficiaries With Alzheimer Disease and Mild Cognitive Impairment

Timothy S. Anderson, MD, MAS¹; John Z. Ayanian, MD, MPP^2,3; Jeffrey Souza, MA⁴; et al Bruce E. Landon, MD, MBA⁴

Author Affiliations

JAMA. Published online September 9, 2021. doi:10.1001/jama.2021.15286

In June 2021, the US Food and Drug Administration (FDA) granted accelerated approval for aducanumab to treat patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer disease (AD), despite limited evidence of clinical benefit. The 2 phase 3 clinical trials of aducanumab, EMERGE and ENGAGE, were stopped prematurely based on prespecified futility thresholds.¹ Both trials also showed an increased risk of adverse events with aducanumab, including microhemorrhages and vasogenic brain edema, headache, and possibly falls.¹ Though both trials excluded patients based on age, certain chronic diseases, and use of antiplatelet agents and anticoagulants, FDA approval was granted without contraindications or precautions for these unstudied patient populations. We evaluated whether patients enrolled in the trials of aducanumab were representative of patients with dementia enrolled in Medicare by estimating the proportions of Medicare beneficiaries with AD or MCI who would have been excluded from the trials.

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