Title TNF-alpha Modulation for Treatment of Alzheimer's Disease: A 6-Month Pilot Study.
Author(s) Tobinick E, Gross H, Weinberger A, Cohen H
Institution Institute for Neurological Research, a private medical group, inc. Los Angeles.
Source MedGenMed 2006; 8(2) :25.
Abstract Context: Current pharmacologic treatments for Alzheimer's disease (AD) do not prevent long-term clinical deterioration. Tumor necrosis factor (TNF)-alpha, a proinflammatory cytokine, has been implicated in the pathogenesis of AD.
Objective: To investigate the use of a biologic TNF-alpha inhibitor, etanercept was given by perispinal extrathecal administration for the treatment of AD.
Methods: This was a prospective, single-center, open-label, pilot (proof-of-concept) study, in which 15 patients with mild-to-severe AD were treated for 6 months. We administered etanercept, 25-50 mg, once weekly by perispinal administration. Main outcome measures included the Mini-Mental State Examination (MMSE), the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), and the Severe Impairment Battery (SIB).
Results: The average age of our patient population was 76.7. The mean baseline MMSE was 18.2 (n = 15); the mean baseline ADAS-Cog was 20.8 (n = 11); and the mean baseline SIB was 62.5 (n = 5). There was significant improvement with treatment, as measured by all of the primary efficacy variables, through 6 months: MMSE increased by 2.13 -/+ 2.23, ADAS-Cog improved (decreased) by 5.48 -/+ 5.08, and SIB increased by 16.6 -/+ 14.52.
Conclusion: An increasing amount of basic science and clinical evidence implicates inflammatory processes and resulting glial activation in the pathogenesis of AD. This small, open-label pilot study suggests that inhibition of the inflammatory cytokine TNF-alpha may hold promise as a potential approach to AD treatment. Further study in randomized, placebo-controlled clinical trials is merited.
Language eng
Pub Type(s) Journal Article
PubMed ID 16926764
(Note: Perispinal etanercept for Alzheimer's is an off-label use which was developed at the Institute for Neurological Research® (INR®), a private medical group, inc. in Los Angeles. This use is neither sponsored by nor endorsed by UCLA. Rather, it is a patented method which is licensed to the INR®. The relevant patents include, but are not limited to, U.S. patents 6,015,557; 6,177,077; 6,419,934; 6,419,944; 6,537,549; and 6,982,089, all issued to Edward Tobinick, MD).
Copyright notice
- TNFMedicine.com © 2007 Edward Lewis Tobinick MD, A Medical Corporation. All Rights Reserved.
Disclaimer
- The views expressed in this blog are my personal thoughts and opinions. I maintain this blog for my own use, to categorize important medical information for myself as it develops. Posts are for informational and educational purposes only. This blog does not constitute medical advice, and none of its posts should be interpreted or relied on as such. This blog does not constitute a solicitation for business. No claims, promises, or guarantees about the accuracy of the information herein are made. Sending me an e-mail does not create a physician-patient relationship. Many of the posts herein contain abstracts and citations which are publically available at www.pubmed.gov, the online medical article database from the National Library of Medicine(which has no affiliation with this site). Many of the posts contain information regarding off-label uses of biologic TNF antagonists. This website should not be interpreted to imply or explicitly make or propose any treatment recommendations. The off-label uses discussed on this website are uses which are, by definition, not FDA-approved. Therefore the safety and efficacy of these uses have not yet been confirmed nor endorsed by the FDA, and no recommendation regarding the use of these reported methods is inferred or implied by their inclusion on this website. Biologic TNF-anatagonists, such as etanercept, infliximab, and adalimumab can have serious adverse effects, such as death, infection, cytopenias, and may be associated with an increased risk of lymphoma, demyelinating disease, eye inflammation, and congestive heart failure. Medical consultation prior to their use is mandatory.
Patent Notice
- The following U.S. patents have been issued to Edward Tobinick MD concerning selected uses of certain biologic TNF antagonists and other cytokine antagonists for selected neurological and related indications in humans: 6,015,557; 6,177,077; 6,379,666; 6,419,934; 6,419,944; 6,423,321; 6,471,961; 6,428,787; 6,537,549; 6,982,089. Also Australian patent 758,523. Additional U.S. and foreign patents are pending.
« Efficacy of etanercept delivered by perispinal administration for chronic back and/or neck disc-related pain: a study of clinical observations in 143 patients. | Main | TNF-alpha Polymorphisms Tied to Alzheimer's Risk. »
January 23, 2007
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