newjerseynewsroom.com

BY CAROL ABAYA

NEWJERSEYNEWSROOM.COM

THE SANDWICH GENERATION

New drugs that show great promise in combating Alzheimer’s Disease (AD) are now in the clinical trials stage. The importance of human testing cannot be understated as every 70 seconds an American develops Alzheimer’s. There are 5 million Americans with AD, and 10 million baby boomers are expected to develop the disease.

Leading the research in New Jersey is Joel Ross, M.D., FACP, AGSF, CMD CPI, of Eatontown. Ross is Founder and CEO of the Memory Enhancement Centers of America, and is certified by the Academy of Pharmaceutical Physicians and Investigators to head research studies. Ross heads six clinical trials of new AD drugs and protocols and drugs to treat MCI (mild cognitive impairment).

The trials encompass drugs (pills and patches), vaccines and infusion therapy. Ross has two other research centers besides Eatontown, each headed by a Board Certified Fellowship Trained Geriatrics Specialist. One center, headed by Abhijit Chatterjee, is in Monroe and the other, headed by Sangif Sharma, is in Toms River.

Ross hopes to expand his research and memory enhancement network in the next few years and have centers in northern New Jersey and New York City. His objective is to identify pre-Alzheimer’s people and those with pre-MCI (Mild cognitive impairment) as early as possible so that treatment can begin.

Through cutting edge pharmaceutical testing of the latest medications, Dr. Ross hopes to “improve the quality of lives of AD patients and their loved ones.”

Ross switched from a geriatric practice to research in 2000. “I was disillusioned with the HMO regulations and how doctors have to practice. I also saw the poor quality of care given to AD patients.

“In reference to Alzheimer’s and various other forms of dementia, no one was really taking care of the research aspect,” Ross notes. “There was – and is – an unmet need for millions of people.”

He said that previous research and existing available AD medicines do not attack the underlying cause of AD – the buildup of plaque in the brain. Current drugs deal with symptoms and have proved ineffective over time.

Noting that 2012 will be a big year for test results in several areas, Dr. Ross says “I am cautiously optimistic that the Pfizer vaccine we are testing will prove effective and be able to dramatically slow down the progression of AD.” Ross notes that this vaccine ACC-001 is geared to stop the buildup of plaque in the brain as well as destroy what is there. This, Ross says, would extend the quality of lifestyle as long as treatment is continued. Ross says the drugs being tested, particularly the vaccine and infusion therapy are disease modifying therapies. They offer hope for longer-lasting improvement in the AD symptoms and progression, Ross says. He points out that like other diseases such as cancer, rheumatoid arthritis, diabetes, the AD drugs that prove effective will have to be taken for the rest of a person’s life.

Alzheimer’s is a disease that attacks the brain and causes the brain to stop functioning normally. No one knows why or how the plaque builds up. There is no known cure and efforts to slow down the progression with several already available pills and patches have over time proved ineffective.

To understand what happens in the AD patient’s brain, years ago an AD expert explained it to me this way:

“Take a handful of paper clips and open them up at various angles. Drop the bunch on a table. You will see that the ends of the paper clips do not touch each other. The brain is like this pile of paper clips. However, in a normal brain electrical impulses will jump from one clip to the next thereby enabling the brain to function appropriately. In AD people, a gummy substance called plaque develops on the ends of the paper clips, thereby preventing electrical impulses from moving through the brain. As more plaque builds up, more brain functions decrease.

AD people lose their memory, ability to do everyday chores, often don’t recognize loved ones, and retreat to childlike behavior. Often organ functions (heart, lungs, kidneys) remain strong until the very end.”

The protocol (method) in Ross’s study that shows the most promise combines two drugs, one a vaccine (AACC-001) that was developed to remove amyloid (plague) from the brain and the second (QS-21) which is supposed to stimulate the body’s immune system to produce antibodies, which may help the body attack and destroy plaque. This study is being conducted at about 20 different research sites in the U.S. and each study is separately run and supervised over a 26 month period of time.

Ross’s study of these two drugs began in 2008, and results are expected to be published next year. If successful, this protocol will be a dramatic breakthrough in treating AD and enabling people to have a better quality of life because there will be less AD related decline over time.

In addition to the vaccine combined with the adjuvant drug, Ross is testing a brand new radiotracer (just developed last year) used in a PET scan (positron emission tomography). This PET scan seems to have a very high accuracy rate in identifying even small amounts of amyloid, brain plaque. If proved to be as effective as initial tests show, this test will be able to identify the plaque at a very early stage of AD. Treatment can then be started at an early stage, with the hope that the existing plaque can be destroyed and the brain inflammation be reduced, thereby allowing the brain to function more normally.

Another procedure being tested by Ross’ group to treat AD and to decrease brain plaque involves infusion of monoclonal antibodies. This process has been successful in developing drugs to treat arthritis, psoriasis, cancer and macular degeneration.

The vaccine and infusion therapy now being studied by Ross are the first to attack the root cause of AD. Both have been developed by Pfizer. The vaccine is given as an injection in the arm. The infusion therapy involves a on e-hour process whereby the drug goes into the vein.

While clinical trials are funded by drug manufacturers, each study is conducted and supervised by independent medical specialists who follow carefully crafted procedures and requires detailed documentation. Ross point out that the drug companies play no role in the trials themselves and do not even know results until the study segment is completed and results published. There is no cost for AD or dementia patients to participate in a clinical trial, and no insurance is needed.

While there still is no complete cure for AD or certain kinds of dementia, in recent years definitive progress has been made in the identification of AD at an early stage, even before symptoms become evident. In the past, AD was only confirmable after death and by an autopsy.