This post may be of interest to three groups:
* those of you following experimental drug therapies for PSP and CBD, both tauopathies (disorders of the protein tau);
* those of you fascinated (frustrated?) by the disconnect between research results and the popular press; and
* those of you tracking low diagnostic accuracy for Alzheimer’s Disease.
Some of you might remember there was an experimental drug called Rember, based on methylene blue. The latest version of Rember is called LMTM, TauRx0236, or LMT-X. Clinical trials of LMT-X in Alzheimer’s recently ended. LMTM is made by TauRx Therapeutics.
For background, see our May 2015 blog post with an update on LMTM:
www.brainsupportnetwork.org/methylene-blue-update/
According to the Alzforum, at a late July 2016 Alzheimer’s conference in Toronto, a researcher “reported that LMTM failed to slow cognitive or functional decline in people with mild to moderate Alzheimer’s disease. On the main primary results slide, disease progression curves for both doses of drug and the placebo were practically identical.” And, yet, later in the presentation, the researcher continued to claim that there was a strong benefit on cognition from the drug in a subgroup.
Alzforum said:
Many researchers in the room, and later in the hallways, were dismayed not only at the way the data were being parsed, but also at media stories about the drug’s ostensible “success.” Outlets such as The Times, New Scientist, and the Huffington Post variously announced the arrival of the first drug to halt Alzheimer’s, or that the drug slowed disease by 80 percent, even while leading Alzheimer’s researchers at AAIC were challenging the company’s leader, Claude Wischik, for overstating the trial’s result.
Paul Aisen, with USC, suggested that not very many people in the LMTM clinical trial actually had Alzheimer’s! Alzforum said:
Aisen further pointed out that the fraction of people in the trial who carried an ApoE4 allele—48, 42, and 53 percent among the placebo, low-, and high-dose LMTM, respectively—seemed low. “In ADCS trials, ApoE4 prevalence among people with mild to moderate AD is typically 60-70 percent,” he said. “Since there was no biomarker to support the diagnosis of Alzheimer’s disease, the low ApoE4 numbers make one wonder about the accuracy of the diagnosis,” Aisen said. “If you rely solely on clinical diagnosis, then you had better have highly experienced clinicians,” he added. In ADNI, the bapineuzumab and first set of solanezumab Phase 3 trials, about a quarter of participants, especially the ApoE4 non-carriers, were later found to be amyloid-negative.
Here are all the details, if you’d like more:
www.alzforum.org/news/conference-coverage/first-phase-3-trial-tau-drug-lmtm-did-not-work-period
In First Phase 3 Trial, the Tau Drug LMTM Did Not Work. Period.
Alzforum
29 July 2016
Robin