Alzheimer’s treatments, this time: there’s always something missing!
The latest report: Donanemab for Alzheimer’s disease
I continue to receive reports on various and sundry scientific papers, purporting to present “breakthrough” scientific studies to the medical profession.
Usually, the “breakthrough” study being reported turns out to have been done in the absence of any attempt to ascertain, let alone to include, the effects of hormonal or metabolic aberration on the patient’s diagnosis, response to therapy or outcome.
The one I received today, “Donanemab in Early Symptomatic Alzheimer Disease”, ClinicalTrials.gov Identifier: NCT04437511, is no exception.
The report is huge and apart from the omission, very well done.
It is an absolutely monumental report on a trial of Donanemab (an immunoglobulin), a G1 monoclonal antibody, which is “directed against insoluble, modified, N-terminal truncated form of β-amyloid present only in brain amyloid plaques”.
Donanemab “binds to N-terminal truncated form of β-amyloid and aids plaque removal through microglial-mediated phagocytosis”.
The authors tried their best
In deference to the authors, John R. Sims, MD1; Jennifer A. Zimmer, MD1; Cynthia D. Evans, PhD1; et al, I must say that this monumentally expensive study appears to have been intelligently designed, carefully supervised and meticulously executed.
It was a Multicenter (277 medical research centers/hospitals in 8 countries), randomized, double-blind, placebo-controlled, 18-month phase 3 trial that enrolled 1736, 65–85-year-old participants, with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology based on positron emission tomography imaging from June 2020 to November 2021.
The paper is a masterpiece.
The paper gives clear evidence that Donanemab, prescribed by itself and without correction of pre-existing hormonal/metabolic aberrations, has beneficial effects on humans with early Alzheimer’s disease. I read it in its entirety, and am impressed with the authors’ attention to detail: I could find nothing to criticise, excepting for one omission which in truth, seems to be present in every clinical trial, nowadays.
The ever-present omission
Clinical trials, perhaps because they are almost always initiated by pharmaceutical companies or by individual physicians who are interested in a drug, procedure or intervention as it applies to a narrow, “specialised” aspect of disease, investigation or therapy, tend to focus sharply on the diagnosis, investigation or therapy being investigated, with little consideration for pre-existing disease, or metabolic aberrations.
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