Posted on 04/12/2008 11:37:55 AM PDT by Lathspell
Scientists claim videos are proof of breakthrough
An injection that dramatically relieved the symptoms of Alzheimer's disease within minutes would qualify as the discovery of the decade. That is exactly what was claimed yesterday for an experimental treatment being tested in America.
Scientists at the Institute for Neurological Research at the University of California have treated around 50 patients at a private clinic by injecting an anti-arthritic drug, etanercept, into the spinal column in the neck and then tilting the patients to encourage the drug to flow to the brain.
They claim 90 per cent respond to the treatment, usually within minutes, and have released videos of patients to prove it.
In one, a nurse sits down with an 82-year-old patient, Marvin Millar, who frowns and mumbles incoherently as she asks him identify everyday objects such as a bracelet and a pencil, which he is unable to do.
But five minutes after being injected with etanercept – according to the film which was supplied and edited by the clinic – he greets his wife. Visibly shocked, she says he has not recognised her for years. Mr Miller then hugs her.
In a separate interview, also supplied by the clinic, she describes his improvements four weeks later, saying he makes sense 90 per cent of the time now, compared with none of the time before treatment started.
After the BBC reported the claims yesterday, callers jammed the Alzheimer's Society's helpline demanding details of the treatment.
Experts urged caution, warning that the drug had been tried on only a very few patients and, crucially, had not been tested against a placebo in a randomised controlled trial.
Etanercept is not a new drug, but this is a novel use of it. The California researchers injected it between the cervical vertebrae at the back of the neck, just below the skull, directly into the spinal column. Tilting is thought to encourage the drug to cross the blood-brain barrier. In arthritis, the drug blocks a chemical – tumour necrosis factor-alpha (TNF) – which causes inflammation and pain in the joints. It is thought TNF may also influence inflammation in the brain, and that by damping down the process the drug may preserve brain function.
Professor Edward Tobinick, who is leading the research, said: "What we see is an improvement in ability to think and calculate, memory improves, verbal ability improves, [patients] find words easier, they seem happier and we often also see an improvement in gait in patients whose gait is affected."
The researchers said improvement usually continued with weekly injections until it reached a plateau at about three months. Some patients had been taking it for three years. But they have only published details of 15 patients in a pilot study.
An estimated 400,000 people suffer from Alzheim-er's disease in the UK and claims for new treatments are seized upon by relatives, desperate for any straw to clutch. Suzanne Sorenson, head of research at the Alzheimer's Society, said she had been sceptical of the claims when she heard about them in January but having seen the film foot-age, considered it was now time to run a trial.
"On the surface these results are exciting but we need to treat the study with caution," she said. "There are large gaps in the resear-ch, which used a small pilot group. We cannot draw conclusions until a controlled trial is carried out."
Clive Holmes, professor of biological psychiatry at Southampton University, a centre for research on dementia, said he was prepared to test the drug.
"The evidence from basic science suggests it is worth giving these drugs a trial to see if there is evidence on a larger basis," he said.
The elusive search for a cure
*A hundred years after Alzheimer's disease was discovered, a cure for the progressive neurodegenerative condition remains a distant dream. Despite dramatic breakthroughsin other areas, there has been little to celebrate in Alzheimer's. The main advance has been drugs to control symptoms such as agitation and restlessness. But restoring memory and cognitive ability has proved much harder.
The condition is caused by an accumulation of protein deposits in the brain which produce the symptoms of dementia.
There are three drugs with claims to halt the disease's progression (though not reverse it), Aricept, Reminyl and Exelon. In 2005 their NHS use was restricted to the moderate stage of the disease – as opposed to early or late stages – by the National Institute for Clinical Excellence because of their limited effect.
It’ll never get approved, ‘cause the FDA will forget what they were approving, by the time they get a ROUND TUIT.
What was that I said????
So, the doctor tells the man that his wife either has AIDS or Alheimers.
The poor guy asks: “How do I know which one she has?”
The doctor says: “Take her for a drive, and drop her off somewhere. If she finds here way back home....don’t go to bed with her.”
Ditto you-me....mine's just gone into "late phase" shortly before her 87th b-day. Dad made it until 94 (seven months ago, just before he died), and he was also a sufferer.
Maybe there's some hope for the family gene pool, however....
I first read about this a few months ago.
All indications are that it is true.
You simply can’t fake the type of results they got.
*Mom survives, and has recently kicked into the 'late stage' phase, so the neurologist prescribed an older drug, Razadyne, and surprisingly it's brought her back just a bit.
I would love to see the ‘clips’ they talked about. (Haven’t read all the replies yet - maybe the link has already been posted!)
My husband has Type II diabetes. He unfortunately ignored his symptoms and has alot of problems (diabetic neuropathy in the feet being one major one). My m-i-l (his mom) also has neuropathy issues (for years, but no diagnosis of diabetes). She is in the ‘early’ late stages of Alzheimers (she is on Aricept along w/other drugs...its an army of \pills). I could go into details, but anyone who has been there ‘knows’ what we are going thru. My prayers are w/you...I’m there too.
Don’t worry, the nursing home lobby will put a stop to this one pronto.
Thanks for the additional links. Much better information than the original article.
This was such an exciting piece of news, I did a little googling. The Alzheimers Research Forum has done a lot of inquiry here http://www.alzforum.org/new/detail.asp?id=1738
Aside from the aforementioned problems with the study, studies, it seems that this NOT a University of California research study as claimed in the Belfast article posted—and many other articles as well. It’s a case study. The Journal of Neuroinflammation, in which the study was published, is an “open-access” publication, not peer reviewed. It sometimes charges to run an article.
Drs. Tobinick and Gross do these injections as part of their private practice, which they call The Institute for Neurological Research. (It’s right next door to Dr. Tobinick’s primary practice—dermatology and laser hair removal.) Looks like reporters glommed on to the Drs.’ UCLA and USC associate professorships on their resumes and assumed it was a UC study.
Dr. Tobinick is evidently on some sort of notice for the use of enteracept mood disorders and as of January 2008, the Medical Board of California lists Tobinick as being on probation for advertising a back pain treatment that’s unproven.
It’s also worth noting that Amgen, makers of entanercept, have distanced themselves from the study, saying they were neither involved in nor supported the study.
http://wwwext.amgen.com/media/rapid_cognitive_improvement.html
All that said, I think this is certainly worth fast-tracking to figure out if it does have value. Just because Tobinick and Gross are doing this for-profit and seem more than a little flaky doesn’t mean it doesn’t work. It may simply mean that they have no interest in treating Alzheimers—just individual Alzheimer’s patients willing to pony up the big bucks at their offices. (You cannot charge patients for research study treatments.) Unfortunately, the way Tobinick has gone about this practically begs the medical community to dismiss this out of hand—which would be a shame, because it seems that most of the objections to
Tobinick’s claims seem not to argue with the underlying premise/science. So it may have promise.
Thank you....too many of us are "there" also. I noted the post (50, I think) about a potential diabetic link; had never heard of that. Neither parent ever had any problem whatsoever with that. My opinion is that people are just plain old living longer, and nature takes this cruel unforseen course.
I was primary caregiver for my mother. For about 5 years.Others casually speak of the conventional red tape of the FDA holding this back for ten years, but there are just too many people and their children and grandchildren who are affected, and too devastatingly, for business as usual to fly.
"Safety" is a red herring issue when the disease is fatal, and catastrophic for the family before the actual fatality. The only serious issue is effectiveness. You'd trade five years of living death for one year of clarity in a heartbeat.
Yep, I was disappointed to notice this as well. While that's not to say it might be an effective treatment, there's a bit left to do before it's peer-reviewed and accepted as an effective treatment by the medical community.
Thanks; thanks for your work.
Health/Life BUMP!
My mom was "diagnosed" (rubber-stamped) with Alzheimer's in 2001. Turns out she doesn't have it. She has some form of senior dementia, but it hasn't progressed like Alzheimer's, and no one really knows what it is. It's been seven years, and she pretty much remembers everyone.
So she'd probably be in the 10%.
in order to prove something, placebos have to be used. Not only do you assess response compared to placebo but you need to compare side effects to placebos.
While sounding promising, we do not know what potentially harmful effects there are.
lef.org is a good place to start. They're often years ahead on cutting edge therapies.
Good post, great summation.
Something has to be done to protect the manufacturer in the event something goes wrong though.
This would be nothing more than an enormous experiment.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.