Brain Aerobics Could be Key to Famous Heart Doctor’s Longevity, Says Alzheimer’s Expert

The late pioneer heart surgeon Michael DeBakey attributed his longevity to genetics and not smoking. However, Alzheimer’s disease and brain longevity expert Dharma Singh Khalsa, M.D. believes that mental exercise and brain aerobics played a big role.

Tucson, AZ, August 06, 2008 --(PR.com)-- Dr. Michael E. DeBakey, one of the United States’ most eminent heart doctors, died recently at the ripe old age of 99 years.

Being the first to develop and perform surgical heart bypass surgery, as well as many other medical innovations, Dr. DeBakey worked and performed surgeries well into his 80’s.

Before his death, he was asked about the secret to his longevity. He gave credit to good family genes and having never smoked.

Dharma Singh Khalsa, M.D., president and medical director of the Alzheimer’s Research and Prevention Foundation (http://www.AlzheimersPrevention.org) — and America’s #1 brain longevity specialist — believes other factors may have also contributed to Dr. DeBakey’s long and active life.

“Just as your body needs strength building activities to keep fit, so does your brain.” Dr. Khalsa explains, “You need to carefully nurture your brain with vigorous mental exercise, what I call ‘brain aerobics’.”

According to Dr. Khalsa, Dr. DeBakey’s ritual of starting his day early in the morning, writing for two hours before leaving his house, working at the hospital until early evening, reading or writing again before bed was key in keeping his brain fit and active.


A diligent course of brain exercises, such as reading and writing everyday, is paramount to staving off age-related memory loss and Alzheimer’s disease.

Numerous studies have shown that memory loss and mental decline do not have to be an inevitable part of the aging process. In fact, Dr. Khalsa says, brain degeneration can be prevented or even reversed through an integrated health program consisting of what he calls the Four Pillars to Building a Better Memory: proper diet and vitamins, stress management, exercise, and medication.

Brain aerobics is an important element of the Four Pillars because it is the key to maintaining a sharp memory. Just like physical exercise increases blood flow and oxygen to the muscles, mental exercise increases blood and oxygen to the brain, thereby improving neural cell growth.

As reported by the non-profit organization Alzheimer’s Research and Prevention Foundation (http://www.AlzheimersPrevention.org) (ARPF), regular participation in brain aerobics has shown to reduce the chances of developing Alzheimer’s disease by up to 70%.

The ARPF, founded by Dr. Khalsa, believes an integrative medical approach utilizing the best of conventional, as well as alternative medical practices such as diet, brain specific nutrients, stress management, physical, and mental exercise, offers the best chance of preventing Alzheimer’s disease.

The Alzheimer’s Research and Prevention Foundation is the leading non-profit organization in the country dedicated to the prevention of memory loss and Alzheimer’s disease. Its mission is to reduce the overall incidence of Alzheimer’s disease through clinical research and to provide public information in the form of educational outreach.

Bradmer reports progression free survival data from previous Phase II glioblastoma multiforme trials

- PFS data from Neuradiab(TM) compares favorably to data from other technologies -

TSX: BMR

TORONTO, July 17 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc. (TSX: BMR), a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, today released progression free survival (PFS) data from two previously conducted Phase II trials of
Neuradiab(TM) in glioblastoma multiforme (GBM) patients. As an exploratory endpoint of the single arm Phase II trials, the data showed a mean overall PFS of 17.2 months in 19 GBM patients treated with Neuradiab. Bradmer is currently conducting a Phase III clinical trial, termed the GLASS-ART Trial, evaluating Neuradiab as an adjunct therapy to the current standard of care for GBM patients. The primary endpoint of the GLASS-ART Trial is the increase in median overall survival in the treated arm compared to the standard of care control arm.

"These PFS data from the Phase II Neuradiab trials exceed the results achieved in any other clinical trial in newly-diagnosed GBM to our knowledge. This is compelling because of recent inquiries from the U.S. Food and Drug Administration (FDA) which suggested that Bradmer may opt to evaluate sensitivities around the merits and use of PFS as an additional interim marker of prognostic benefit," said Dr. Alan M. Ezrin, President and Chief Executive Officer of Bradmer. "While the GLASS-ART Trial is being conducted with a clear primary endpoint of median overall survival, the opportunity for Neuradiab to demonstrate a patient benefit via the parameter of PFS could provide an augmented regulatory approval path. We have examined the PFS outcomes from the previous studies of Neuradiab and intend to discuss with the FDA the most appropriate method in which to use PFS data from the GLASS-ART Trial."

Recent communications from the FDA have led Bradmer to consider using PFS data not only as a secondary endpoint in the GLASS-ART Trial but to evaluate such data in a blinded and centrally reviewed manner in order to be able to use the PFS data for additional labeling consideration. As the trial is currently designed, PFS data is being collected as an exploratory secondary endpoint. New regulatory submissions can include secondary endpoint data to support labeling claims for registration purposes if the data are collected in an acceptable manner. In some cases, secondary
endpoint data can also provide early insight into patient benefit from an ongoing Phase III trial.

A recent article published in Neuro-Oncology (Lamborn et al, 2008) examined six-month progression free survival as a predictor of overall survival in glioma patients. The article included data from 597 adult patients with recurrent high-grade gliomas that enrolled in Phase II trial
protocols collected by the North American Brain Tumor Consortium between 1998 and 2002. The study concluded that progression status at 9, 18, and 26 weeks were strong predictors of survival and that progression free survival is a valid endpoint for trials of therapies for recurrent malignant glioma.

Bradmer's PFS analysis is based on 19 GBM patients in two recent single-arm Phase II trials of Neuradiab with a targeted dose of 44 Gy delivered as an adjunct to the current standard of care consisting of surgery, temozolomide and external radiation therapy (study 01128; n = 21
(Reardon et al., J Neuro-Oncology, Doc. D06-00199, February 20, 2008) (http://neuro-oncology.dukejournals.org) (DOI:10.1215/15228517-2007-053) and study 05018; n = 5).

In addition, Bradmer has reviewed the existing external GBM literature, and in nine of the eleven studies published between 2003 and 2008 by outside parties that the Company analyzed, progression free survival ranged from 4 to 10 months, with two other studies achieving 13 month and 17 month PFS results. The results from the external studies covered 16 different newly diagnosed GBM patient populations receiving various combinations of approved and investigational therapies. Bradmer has submitted its PFS data (Reardon et al.) as an abstract for inclusion at the 13th Annual Scientific Meeting of the Society of Neuro-Oncology to be held in November, 2008.

About the GLASS-ART Trial (http://www.glassarttrial.com)

The Phase III GLASS-ART trial derives its name from its description: GBM Locoregional Agent Survival Study - Antitenascin Radiolabeled antibody Therapy Trial. The study is designed to determine the survival benefit derived from, and safety of, adding Neuradiab(TM) to the current standard of care therapy, consisting of surgery, radiation and adjuvant chemotherapy
(temozolomide), for patients diagnosed with primary glioblastoma mulitforme. The randomized trial will enroll up to 760 patients at leading treatment centers across the United States. The goal of the GLASS-ART trial is to replicate the increase survival benefit recently reported by investigators from Duke University in patients treated with Neuradiab(TM) (Reardon et al., in J Neuro-Oncology, Doc. D06-00199, February 20, 2008) (http://neuro-oncology.dukejournals.org) (DOI:10.1215/15228517-2007-053).
Additional information on the trial can be found at http://www.glassarttrial.com or at http://www.clinicaltrials.gov and then by searching the term "Bradmer" or the study identifier NCT00615186.

About Neuradiab

Neuradiab is a monoclonal antibody, conjugated to radioactive iodine, used to treat glioblastoma multiforme (GBM), the most common and most advanced form of brain cancer. Neuradiab(TM) delivers tumor-killing radiation specifically to residual brain tumor cells after surgery, with minimal impact on normal brain tissue. During the course of development at Duke University, over US$60 million in research grants and related support has produced a series of Phase I and Phase II clinical trials on Neuradiab(TM) and other closely related technologies. Approximately 200 brain cancer patients, including over 160 with GBM, have been treated with the Neuradiab therapy regimen, and survival benefits have significantly exceeded historical controls in each completed trial. Neuradiab(TM) has been formerly referred to in literature as 131I anti-tenascin monoclonal antibody 81c6.

Each year up to 30,000 new cases of GBM are diagnosed in the world's seven largest healthcare markets. The current standard of care for GBM patients is surgical resection followed by radiation and temozolomide. GBM tumors typically have infiltrating edges that are very difficult to completely remove with surgery. The Neuradiab(TM) therapy is delivered directly into the surgical resection cavity in a separate procedure after the initial surgery. Neuradiab(TM) delivers a concentrated level of radiation specifically to the remaining cancer cells by targeting tenascin. Tenascin is a protein over-expressed in 99% of GBM cells but absent from normal brain cells.

normal pressure hydrocephalus

What is normal pressure hydrocephalus?

Normal pressure hydrocephalus, or NPH, is an acquired hydrocephalus that most often occurs in people over age 60. NPH is different from typical hydrocephalus in that it may not cause an obvious increase of pressure in the head, but may have fluctuations in CSF pressure from high to normal to low.

What are the symptoms of NPH?

There are three classic symptoms of NPH. They are referred to as the classic triad of symptoms:

• Difficulty walking — This problem can be mild or severe. In many cases, people with NPH have trouble picking up their feet. Some describe it as feeling like their feet are stuck to the floor. This can lead to a shuffling walk, and problems going up stairs and curbs. It also increases the risk of falling.
• Dementia — This often involves confusion, short-term memory loss, and a lack of interest in daily activities.
• Problems with bladder control — Problems include urinary incontinence (the inability to hold urine), frequent urination, and a strong feeling of needing to urinate.

Most patients with NPH do not have headaches, which are common in patients with obstructive hydrocephalus.

What causes NPH?

Many cases of NPH have no known cause. Some cases of NPH are linked to bleeding in the brain or a blockage in CSF flow through and around the brain and spinal cord. It is believed that blockages are linked to a history of infection, stroke, or head injury.

How common is NPH?

Because the symptoms of NPH are similar to those of other diseases, people with NPH are often diagnosed with disorders such as Alzheimer's or Parkinson's disease, or the symptoms may be attributed to the aging process. For that reason, it is difficult to know how many people actually have NPH. However, it is estimated that as many as 10 percent of people with dementia attributed to other disorders may actually have NPH.

How is NPH diagnosed?

A careful review of symptoms, a medical history, and various tests are used to diagnose NPH. Tests used may include:

• Computed tomography (CT) — A CT scan is a diagnostic tool that uses X-rays and a computer to create pictures of structures inside the body. A CT scan can provide images that show the size of the ventricles.
• Lumbar puncture for NPH — Also called a spinal tap, this procedure is used to remove a sample of the CSF. For NPH, this test is used to determine if a person’s symptoms improve after removing a large amount of fluid. About 1 to 1½ oz. of fluid is removed. However, this test is not definitive.
• NPH protocol — The protocol entails a series of screening procedures, including a gait analysis, blood work, and neuropsychiatric testing. It also involves the removal of CSF through a special catheter (tube) over a 36-hour period. It is expected that following removal of CSF, there will be a dramatic, temporary relief of symptoms. The protocol also provides the surgeon with information about the potential benefit of implanting a shunt, which is a device that drains excess CSF away from the brain and spinal cord, diverting it to another part of the body, such as the abdomen or heart, where the body can absorb it.
• Magnetic resonance imaging (MRI) — An MRI scan uses a magnet and radio waves, instead of X-rays, to produce images.
• Gait analysis (walking) — This is a timed walk test. The patient is watched as he or she walks 10 meters (about 30 feet).
• Neuropsychological testing — This involves a series of questions used to see if there is a loss of brain function caused by NPH.

How is NPH treated?

NPH may be treated using an implantable shunt to drain excess CSF away from the brain and spinal cord.

What complications are linked to NPH treatment?

Complications of NPH treatment are those associated with any surgical procedure. They include bleeding, infection, and reaction to the anesthesia used during surgery. Patients might also experience mild abdominal pain. Seizures also may occur as surgery on the brain can affect very sensitive areas of the brain. Fortunately, these complications are not common, and in most cases can be successfully treated.

What is the outlook for people with NPH?

With treatment, the symptoms of NPH can be partially or even fully reversible. On the other hand, the outlook is poor when the disorder is not treated appropriately. Without treatment, the symptoms can continue to worsen and lead, eventually, to death.

Is there any way to prevent NPH?

Right now, there is no known way to prevent NPH. However, getting treatment as soon as symptoms appear can improve those symptoms and increase the chance for a full or partial recovery.

Source: Cleveland Clinic