Posted on 01/09/2008 2:14:21 PM PST by blam
Reversal Of Alzheimer's Symptoms Within Minutes In Human Study
PET Scan of Alzheimer's Disease Brain. (Credit: NIH/National Institute On Aging)
ScienceDaily (Jan. 9, 2008) — An extraordinary new scientific study, which for the first time documents marked improvement in Alzheimer’s disease within minutes of administration of a therapeutic molecule, has just been published in the Journal of Neuroinflammation.
This new study highlights the importance of certain soluble proteins, called cytokines, in Alzheimer’s disease. The study focuses on one of these cytokines, tumor necrosis factor-alpha(TNF), a critical component of the brain’s immune system. Normally, TNF finely regulates the transmission of neural impulses in the brain. The authors hypothesized that elevated levels of TNF in Alzheimer’s disease interfere with this regulation. To reduce elevated TNF, the authors gave patients an injection of an anti-TNF therapeutic called etanercept. Excess TNF-alpha has been documented in the cerebrospinal fluid of patients with Alzheimer’s.
The new study documents a dramatic and unprecedented therapeutic effect in an Alzheimer’s patient: improvement within minutes following delivery of perispinal etanercept, which is etanercept given by injection in the spine. Etanercept (trade name Enbrel) binds and inactivates excess TNF. Etanercept is FDA approved to treat a number of immune-mediated disorders and is used off label in the study.
The use of anti-TNF therapeutics as a new treatment choice for many diseases, such as rheumatoid arthritis and potentially even Alzheimer’s, was recently chosen as one of the top 10 health stories of 2007 by the Harvard Health Letter.
Similarly, the Neurotechnology Industry Organization has recently selected new treatment targets revealed by neuroimmunology (such as excess TNF) as one of the top 10 Neuroscience Trends of 2007. And the Dana Alliance for Brain Initiatives has chosen the pilot study using perispinal etanercept for Alzheimer’s for inclusion and discussion in their 2007 Progress Report on Brain Research.
The lead author of the study, Edward Tobinick M.D., is an assistant clinical professor of medicine at the University of California, Los Angeles and director of the Institute for Neurological Research, a private medical group in Los Angeles. Hyman Gross, M.D., clinical professor of neurology at the University of Southern California, was co-author.
The study is accompanied by an extensive commentary by Sue Griffin, Ph.D., director of research at the Donald W. Reynolds Institute on Aging at the University of Arkansas for Medical Sciences (UAMS) in Little Rock and at the Geriatric Research and Clinical Center at the VA Hospital in Little Rock, who along with Robert Mrak, M.D., chairman of pathology at University of Toledo Medical School, are editors-in-chief of the Journal of Neuroinflammation.
Griffin and Mrak are pioneers in the field of neuroinflammation. Griffin published a landmark study in 1989 describing the association of cytokine overexpression in the brain and Alzheimer’s disease. Her research helped pave the way for the findings of the present study. Griffin has recently been selected for membership in the Dana Alliance for Brain Initiatives, a nonprofit organization of more than 200 leading neuroscientists, including ten Nobel laureates.
“It is unprecedented that we can see cognitive and behavioral improvement in a patient with established dementia within minutes of therapeutic intervention,” said Griffin. “It is imperative that the medical and scientific communities immediately undertake to further investigate and characterize the physiologic mechanisms involved. This gives all of us in Alzheimer’s research a tremendous new clue about new avenues of research, which is so exciting and so needed in the field of Alzheimer’s. Even though this report predominantly discusses a single patient, it is of significant scientific interest because of the potential insight it may give into the processes involved in the brain dysfunction of Alzheimer’s.”
While the article discusses one patient, many other patients with mild to severe Alzheimer’s received the treatment and all have shown sustained and marked improvement.
The new study, entitled “Rapid cognitive improvement in Alzheimer’s disease following perispinal etanercept administration,” and the accompanying commentary, entitled “Perispinal etanercept: Potential as an Alzheimer’s therapeutic,” are available on the Web site of the Journal of Neuroinflammation.
Author Hyman Gross, M.D., has no competing interests. Author Edward Tobinick, M.D. owns stock in Amgen, the manufacturer of etanercept, and has multiple issued and pending patents assigned to TACT IP LLC that describe the parenteral and perispinal use of etanercept for the treatment of Alzheimer’s disease and other neurological disorders, including, but not limited to, U.S. patents 6015557, 6177077, 6419934, 6419944, 6537549, 6982089, 7214658 and Australian patent 758523.
Adapted from materials provided by University of Arkansas for Medical Sciences.
Wow. Thanks for the ping.
I just checked out the article, but couldn’t find the commentary on it listed there. It’s not intrathecal but rather extrathecal hoping for delivery via paraspinal vessels. And it uses the standard 25 mg weekly dose schedule so would cost the same as RA treatment plus some charge for the skilled person required to inject it that way weekly. Drug costs ~$15k/year still might be paid for if it kept patients out of nursing homes. Sounds like a great excuse for further studies to optimize the dosing and results and also to compare other routes of delivery (does it have to be paraspinal or would subcutaneous also work) and the other TNF blockers. And also to collect data on the possible risk of demyelinating disorders from this usage.
At $900 a dose it’s still cheaper than assisted living which can run in the thousands per month....
sw
Printing and taking to work with me tomorrow.
May or may not be of help to some of our patients but hope is hope.
Makes me want to cry, this article published on what would have been my mother’s 93rd birthday. She spent the last 25 years of her life in a mental muddle that required her to live in a locked facility. Not a nice way to live or to die.
And yet, she had her moments of clarity — not many, but it was as though she had a veil over her brain. When the light shone in, the old humor, wit, personality, intelligence and memory seemed intact. For maybe two minutes. Then the light in her eyes would die, the words turned into incomprehensible mutterings and she’d shuffle away.
I really hope they’ve nailed a cure. No one should have to go through this.
The difference is that these actually exist now, and must make their way through clinical trials, which takes years.
So instead of academics saying "in 5 - 10 years we should have something", it's biotechs saying "we have something *now*, and we should be done with trials and development in 5 years."
“A drop in the bucket compared to what we give countries that hate our guts.”
_____________________
Sigh....so true, Fishhawk.
You sound like me to a “T”.
I also tear up at pictures of Reagan. From all I have read, he was a decent, caring man who unanbashedly fought the evils of communism. I believe God used RR as His agent(along with Maggie Thatcher and Pope John Paul VI) to put the final nail in the Soviet Union and to bring freedom to hundreds of millions of people. RR was a man of tremendous personal courage.
I well remember living through Jimmy Carter and the Reagan years—like night and day. I always felt safe when RR was on duty, in spite of the vicious press he got.
To this day, I have no use for the MSM. They do the same things to President Bush.
I often wonder what the 1990s would have been like with a sharp RR scolding Bill Clinton for his errant ways. Bildo would have been a one termer for sure.
Isn’t that what it already is?
Excellent.
Cheaper than a nursing home.
The good news is that it can be prescribed "off-label" as long as the patient and doctor realize they're playing games with the patient's life. The downside is that you can die if you don't get it right. And animal models are only partly accurate in adjusting dosage. You want to get every possible avenue as close as possible before you start - there's no other phrase for it - experimenting on patients. You can imagine the immense medical ethics issues involved here.
It will cut into a lot peoples' business'.
Yeah, I’ve been taking it since 2001. But I didn’t get the impression from the article that the same dosing schedule would be followed for this use.
Got me thinking, though-—folks here who take Enbrel might respond with their thoughts. I still have some residual pain that can get quite bad. Finally the docs called it nerve pain and have treated it as such with some success.
Since this spinal injection treats neuroinflammation, it got me thinking about ways it might help with other nerve conditions.
I think there’s no question this would be cheaper than nursing home care. The drug is already approved for RA and psoriatic arthritis, JRA and maybe some other stuff. Plus many doctors will prescribe it for other rheumatic diseases if DMARDs, etc. fail.
Seems it would be easy to extend use to this. Plus, it can be given to people at the first signs of dementia, I would think.
The article made it sound as though the effect might be pretty durable.
Seems like this would become a “procedure” you go to a special center to have done, like getting an MRI or something.
One doc prescribes it, the specialist does the spinal infusion.
All I can tell you is Enbrel is a miracle drug for the people for whom it works (not everyone benefits, of course).
I know people who were in a wheelchair for many years and now walk after taking Enbrel!
No, I wouldn’t guess a spinal twice a week would be too likely but you never know. You ever have any injection site issues?
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