Issue 10, volume 4, Supplement of Alzheimer’s and Dementia: Journal of the Alzheimer’s Association, Session 04-11-02, P273, entitled “The Safety and Tolerability of etanercept in Alzheimer’s disease (STEADI-09): A Phase II Double Blind Randomised Placebo Controlled Trial”, principal investigator Clive Holmes MD, University of Southampton, Southampton, United Kingdom, contains the first double-blind, randomized, placebo-controlled data supporting the therapeutic efficacy of etanercept for treatment of Alzheimer’s disease. The abstract of this study (full-text here) published in this issue in July 2014. The abstract concludes:
“This study shows good tolerability and safety of Etanercept in the subjects with Alzheimer’s Disease. This study is also supportive of beneficial cognitive, behavior and activities of daily living in subjects taking subcutaneous Etanercept.”
A 2008 article in BBC News had previously discussed the favorable results of etanercept for treatment of Alzheimer’s disease in a study whose lead author was Edward Tobinick M.D. The article reported at the time that Clive Holmes MD was interested in taking on further research utilizing this treatment approach.
May 10, 2014
Two scientists from the UCLA Department of Neurology have published a new research article entitled “Intracerebral hemorrhage in mouse models: therapeutic interventions and functional recovery“, Metab Brain Dis. 2014 epub May 10.
The authors recognize intracerebral hemorrhage as a subtype of focal stroke and the most common form of brain hemorrhage. The authors explain,
“With direct blood extravasation into brain, secondary inflammation is a substantial feature. Drugs which reduce neuroinflammation enhance functional recovery. Lei and colleagues targeted tumor necrosis factor alpha (TNF-alpha), a cytokine that is secreted by the microglia in response to injury and acts as a prime neuroinflammatory mediator causing progressive damage. A single dose of TNF-alpha antibody … showed evidence of reduced neuroinflammation and improved functional deficit….”
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December 18, 2013 (Gold Coast, Australia): Today Griffith University, on their Alzheimer’s trial website, announced that the Griffith University Alzheimer’s Study has recently been granted full approval by the Human Research Ethics Committee as the first randomized double blind clinical trial to test perispinal etanercept for dementia in Australian patients. More information here, on the Griffith website. The INR congratulates Griffith University and its scientists and physicians for their diligence and outstanding efforts that have enabled the initiation of this new study. The approval and initiation of this new study represents independent scientific support for the scientific rationale underlying this treatment approach that was invented and pioneered at the INR in Los Angeles.
November 1, 2013: A new randomized study published in the November 1, 2013 issue of the journal Spine (Freeman, B.J., et al., Randomized, Double-blind, Placebo-Controlled, Trial of Transforaminal Epidural Etanercept for the Treatment of Symptomatic Lumbar Disc Herniation. Spine (Phila Pa 1976), 2013. 38(23): p. 1986-94) provides new evidence for the efficacy of a TNF inhibitor for relief of persistent sciatica associated with lumbar disc herniation. Etanercept is a potent anti-inflammatory drug that is a selective blocker of an immune signaling molecule called TNF. Local perilesional methods of administration of etanercept, including epidural injection for treating sciatica associated with lumbar disc herniation were invented by Edward Tobinick M.D. more than a decade earlier (U.S. patent 6,419,944; 6,537,549; and others).
The new Spine study now constitutes the third published favorable clinical trial providing randomized, controlled trial (RCT) data of the efficacy of etanercept for treating sciatica. Dr. Tobinick was the first to publish human data reporting the effectiveness of etanercept for this indication in 2003, with a larger study published in 2004 (Tobinick, E. and S. Davoodifar, Efficacy of etanercept delivered by perispinal administration for chronic back and/or neck disc-related pain: a study of clinical observations in 143 patients. Curr Med Res Opin, 2004. 20(7): p. 1075-85).