Alzheimers

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FRIDAY, April 22 (HealthDay News) -- Regular infusions of plasma derived antibodies appear to reduce levels of Alzheimer's disease-causing brain plaques while improving patients' thinking ability, researchers report.

Buildup of beta-amyloid protein plaques in the brain is a hallmark of Alzheimer's and toxicity related to this buildup is thought to be a major cause of the disease, for which there is currently no effective treatment.

In this phase I clinical study, conducted by a team from New York-Presbyterian Hospital/Weill Cornell Medical Center, researchers gave patients with mild to moderate Alzheimer's periodic infusions of a targeted antibody, called immunoglobulin (IVIg). The antibody makes its way to the brain where it targets beta-amyloid for removal.

The study included eight Alzheimer's patients treated with IVIg. After six months of treatment, seven of the patients underwent cognitive testing. The tests showed that cognitive function stopped declining in all seven patients and had actually improved in six of the seven patients.

"If these results are confirmed in larger, controlled trials, we might have a safe Alzheimer's treatment capable of clearing the amyloid protein away," senior researcher Dr. Marc E. Weksler said in a prepared statement.

The study was presented at the recent annual meeting of the American Academy of Neurology in Miami.

The researchers emphasize that it's too soon to describe IVIg as anything more than promising, and they do not recommend that doctors treat Alzheimer's patients with IVIg at this point in time. Preparations are already underway for a larger, controlled Phase II clinical trial of IVIg, the researchers said.

IVIg is an antibody product derived from human plasma. The U.S. Food and Drug Administration has long approved the use of IVIg to treat other conditions, but not Alzheimer's.

It has been well known that Alzheimer's causes beta amyloid deposits in the brain. Antibodies against beta amyloid can be measured in C.S.F. these antibodies are reduces in patients who go on to develop Alzheimer's. IVIg contains these antibodies so it is no miracle that it helps stop the disease in its track.

Frequently Asked Questions About IVIG and Alzheimer's

What is IVIg? IVIg stands for IntraVenous Immunoglobulin. It is a product of human blood that is derived from the plasma of thousands of healthy volunteers. IVIg contains antibodies, which are the proteins that help protect the body against disease.

Why is IVIg being studied as a treatment for Alzheimer's? It was recently discovered that IVIg contains antibodies that bind to beta amyloid (A�). A� is a protein that many scientists believe is important in causing Alzheimer's. IVIg may help to promote the clearance of A� from the brain and block A�'s toxic effects on brain cells.

Is IVIg a new treatment? IVIg was originally approved by the U.S. Food and Drug Administration for treating immune disorders and has been available for more than 30 years. IVIg is FDA-approved for the treatment of patients with primary immunodeficiencies, immune thrombocytopenic purpura (ITP), B-cell chronic lymphocyctic leukemia (CLL), Kawasaki syndrome, and immunodeficiency associated with pediatric HIV and bone marrow transplantation.

Neurologists also use IVIg in the treatment of multiple sclerosis and motor neuropathy, though IVIg is not approved for these conditions. It is--not currently approved to treat Alzheimer's disease, but is under study for that purpose.

How is IVIg treatment given? IVIg is administered by an infusion into a vein, a process that typically takes several hours. It is believed that infusions have to be carried out at least once or twice a month in Alzheimer's patients.

Is IVIg safe? Several hundred thousand persons have received IVIg over the years, and it is generally well-tolerated. There may be added risks to its use in elderly individuals with Alzheimer's, but many older persons have received IVIg without difficulty.

Because it is derived from human plasma, IVIg carries with it a very small risk of communicable diseases such as Hepatitis and HIV. However, in the United States there have been no documented cases of transmission of these diseases by IVIg over the past 10 years.

Other possible risks relating to use of IVIg include kidney failure, stroke, lung problems, heart failure, allergic reactions and other problems. The likelihood of these complications occurring can be reduced by screening out persons who have known risk factors and administering the IVIg in modified forms.

Is IVIg costly? IVIg is very expensive compared to medications currently in use to treat Alzheimer's disease. One month of treatment typically costs $5000-$10,000---- including the expense of the IVIg itself, the infusions and other costs.

How effective is IVIg in Alzheimer's? So far, only two clinical studies have been carried out examining the effects of IVIg in Alzheimer's disease at a mild to moderate stage of the illness. Collectively, a total of 13 patients were treated in these two studies, which is too small a number to establish whether or not the treatment works. IVIg was well-tolerated by the AD patients treated and none were noted to decline in their thinking abilities over 6 months of treatment. A majority of the patients improved on simple measures of thinking ability.

Many more persons with Alzheimer's will need to be treated in blinded studies that incorporate placebo controls before the usefulness of IVIg can be determined.

There are different "brands" of IVIg. Are they all the same? The various manufacturers of IVIg use different preparation processes, which could affect the usefulness of their product for treating Alzheimer's. The various brands of IVIg have not yet been compared in actual Alzheimer clinical trials, so it is not known whether they are all equivalent. Products made by Baxter Healthcare and Octapharm have been tested and both yielded positive effects.

How long will IVIg need to be given if it proves effective in treating Alzheimer's? It is not known how long treatment will need to be continued at this time.

Can my doctor prescribe IVIg for Alzheimer's? In theory, since IVIg is commercially available, it can be prescribed by a licensed physician. However, since the optimal dosing, preparation and patient for this treatment have yet to be determined, it is--not recommended that physicians use IVIg for this purpose at this time except in experimentally controlled clinical studies (trials). Since it is not approved to treat Alzheimer's disease, Medicare and third-party payers may choose not to pay for this treatment.

Office of Public Affairs NewYork-Presbyterian Hospital/Weill Cornell Medical Center 525 East 68th Street, Box 144 New York, NY 10021

Caution urged in Alzheimer's study
Much more research is needed, doctors say, into the effectiveness of arthritis drug Enbrel.
By Shari Roan, Times Staff Writer
June 26, 2006

Reports of success in treating Alzheimer's disease using injections of the arthritis drug Enbrel have sparked hope among Alzheimer's patients and their families � and some concern among physicians.

A recent study reported improvement in cognitive symptoms among 15 Alzheimer's patients who received weekly injections of Enbrel for six months. But doctors not involved in the research say the publicity surrounding it could lead Alzheimer's patients or their family members to believe Enbrel is a proven treatment for the disease when the study actually reflects interesting, but preliminary, research.

The pilot study was published in April by Dr. Edward Tobinick of Institute Research Associates in Los Angeles, along with three co-authors, in the peer-reviewed, electronic medical journal Medscape General Medicine.

The research explored whether Enbrel can reduce the activity of an inflammation-producing substance called tumor necrosis factor-alpha in the brains of Alzheimer's patients.

The 15 patients were injected in the back of the neck, above the spine. The study cited "a sustained and significant improvement in cognition" in both mild and more severe cases.

But Alzheimer's experts who were not involved in the study say it's too early to determine if the therapy offers real benefits because it was a small pilot study. They said a randomized, controlled trial was needed, in which some patients receive the drug and some do not, while the investigators remain unaware as to who is receiving medication.

"It's an uncontrolled study; that's important because many studies which look promising in an open study end up not being successful," says Dr. P. Murali Doraiswamy, a Duke University psychiatrist who is on the Alzheimer's Foundation of America's medical advisory board. "The study is too small for any reasonable conclusions to be drawn."

The concept behind the study � using a novel route to deliver an anti-inflammatory drug � is intriguing, says Doraiswamy. But previous research using other anti-inflammatory drugs in Alzheimer's patients has failed, he says. The Alzheimer's Foundation of America does not advocate the use of anti-inflammatory drugs because of the lack of evidence that they work.

Moreover, anti-tumor necrosis factor medications, including Enbrel, have been associated with rare but serious side effects, says Dr. George Bartzokis, a neurology professor and director of the clinical core of the Alzheimer's Disease Research Center at UCLA. Enbrel is linked to infections and symptoms of multiple sclerosis.

Experts also questioned whether the drug could reach the brains of patients. Tobinick says he injected it in the neck for closer proximity to the brain.

"The delivery of this drug is fairly unusual," says Freddi Segal-Gidan, a gerontologist and co-director of the Rancho Los Amigos-USC Alzheimer's Disease Research Center. "We have what is called a blood-brain barrier that is to protect the brain from agents getting in. It's unclear how much of this agent was able to get into the brain."

Tobinick, however, called the positive results "unprecedented" and says he is eager for other researchers to test the therapy.

"We would argue that this is urgently necessary due to the unmet medical needs being addressed and the degree of clinical improvement which was observed and documented," he says. "The degree of improvement and duration of improvement over six months both argue against � a placebo effect."

Tobinick, a dermatologist and internist, holds patents for his Enbrel treatment methods and owns stock in Amgen Inc., which makes Enbrel. He offers Enbrel to selected Alzheimer's patients outside of clinical studies..

The other three co-authors of the Alzheimer's paper have no financial interest

The study was presented at the recent annual meeting of the American Academy of Neurology in Miami.

IVIg is an antibody product derived from human plasma. The U.S. Food and Drug Administration has long approved the use of IVIg to treat other conditions, but not Alzheimer's.

Frequently Asked Questions About IVIG and Alzheimer's

Many more persons with Alzheimer's will need to be treated in blinded studies that incorporate placebo controls before the usefulness of IVIg can be determined.

How long will IVIg need to be given if it proves effective in treating Alzheimer's? It is not known how long treatment will need to be continued at this time.

Office of Public Affairs NewYork-Presbyterian Hospital/Weill Cornell Medical Center 525 East 68th Street, Box 144 New York, NY 10021

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18 Foods That Make Your Skin Glow
Posted Wed, Mar 19, 2008, 1:20 pm PDT

Top skin creams average about $400 an ounce (and you thought gas was expensive!), yet most offer little proof that they do half of what they promise. Want to save a bundle and improve your skin? Load your shopping cart with nutrients that research has shown to have skin-hydrating, sun-protecting, and even wrinkle-preventing powers, says Manhattan dermatologist Amy Wechsler, MD. Here�s her grocery list of best foods for your skin.

Firm and Bright
You�re probably up to your eyebrows (Botoxed or not) with hearing �eat more fruits and vegetables.� But if you have yet to take that advice to heart, maybe knowing that they prevent wrinkles will do the trick. The colorful pigments that produce bright orange and red also refill antioxidant levels in your skin.
The skin doc�s 3 top picks: SWEET POTATOES, TOMATOES, CANTALOUPE
What they do: Replenish your skin�s supply of antioxidants, so they're ready to scarf up free radicals whenever they make an appearance. Free rads are highly reactive oxygen molecules that damage cells and contribute to just about everything that can go wrong with skin, from dryness to crinkles.

Fresh and Juicy
Your body can�t store much wrinkle-fighting vitamin C, so you need to keep your supplies stocked. The easiest, simplest way: Have some citrus every day.
The skin doc�s 4 top picks: ORANGES, LEMONS, LIMES, GRAPEFRUIT

Actually, ounce for ounce, oranges are the top citrus C source but you can only eat so many, right? For variety, make lemonade, squeeze limes on melon, add grapefruit to salad, and instead of drinking soda, fizz up OJ with sparkling water. It all adds up.
What they do: Keep skin�s vitamin C levels high. While C�s a nifty antioxidant, that�s not the key reason it�s here. It helps keeps collagen -- the supportive protein fibers that stop skin from sagging -- strong and resilient. (Flimsy collagen means lines and wrinkles.) Since collagen breakdown really picks up in your mid-30s, eat citrus early and often to head off aging.

Smoothing and Soothing
There�s a particularly potent antioxidant known as EGCG that does all kinds of good things for skin. The best place to find it? True teas: black, green, or white (not herbal). Brew a teapot full every morning, so that sipping four to six cups throughout the day is a no-brainer.
The skin doc�s #1 pick: GREEN TEA

While all true teas contain EGCG (epigallocatechin-3-gallate), the various types of green tea have the most. Wechsler�s personal favorite is green tea ). �The roasting process that turns this green tea a brownish color also lowers its caffeine content,� she says -- handy if you�re caffeine sensitive or it�s one of those days when you do not need another stimulant.
What it does: Gives your skin a healthy dose of EGCG, which is a great multi-tasker. EGCG puts a damper on inflammatory chemicals involved in acne and sun-related skin aging; it also helps prevent skin cancer; and it has a lion-tamer effect on tumor cells. What�s more, green tea contains L-theanine, a de-tensing amino acid -- and anything you can do to staunch the flow of the stress hormone cortisol helps keep collagen fibers intact.

Green and Leafy
Certain dark leafy greens, whether they�re fresh, frozen, raw, or steamed, really deliver on vitamin A, one of the most skin-essential vitamins going.
The skin doc�s 3 top picks: SPINACH, TURNIP GREENS, BROCCOLI
What they do: Deliver a hefty supply of vitamin A, which supports skin cell turnover, the process that keeps cell growth and development humming along flawlessly. Without enough A, skin becomes dry, tough, and scaly.

Fisherman�s Faves
Several cold-water catches give your skin a double benefit: age-fighting omega-3 fatty acids plus the restorative powers of protein.

The skin doc�s 7 top picks: SALMON, TROUT, TUNA, ATLANTIC MACKEREL, SARDINES, PACIFIC HERRING, MOST SHELLFISH

Just don�t, uh, go overboard. As good as omega-3s are for skin (and the rest of you, too), worries about the amount of mercury in many fish mean it�s smart to limit seafood to two meals a week. That�s a must for women who are or might become pregnant or are nursing, and for young children, too.

What they do: Omega-3s fight inflammation, now considered one of the top skin-agers, and they also help protect against sunburn, enhancing the effects of your SPF sunscreen. Protein is required to build and repair skin cells and to make enzymes and hormones that help keep it glowing.

Fill your weekly grocery cart with all of the above foods and you won�t just look younger, you�ll be younger. Eating at least 1 serving of fish a week and getting the right amount of antioxidants through diet or supplements lower your biological age. In fact, the antioxidants alone can make your RealAge up to 6 years younger.

Tissue Salts

For a short-term problem, tissue salts can help restore order. Take 4 tablets under the tongue three times daily for two to three weeks.

Kali phos helps nervous depression from grief and worry. It is the principal tissue salt for the nerves and should be used alternately with other remedies.

Nat mur is indicated for depressed spirits and feelings of hopelessness. This sadness is typically accompanied by headaches and constipation.

Nat sulph relieves depression following an injury to the head.

Calc phos helps with wandering thoughts and poor concentration.

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