Friday, July 10, 2009

Lake Charles Tapped As Alzheimer’s Study Site


By Chaney Ferguson
The Times of SWLA




Nearly a year ago Lake Charles was chosen as an Alzheimer’s study site. A team located in Memorial Hospital, led by Dr. Kashinath G. Yadalam, is working with volunteers (age 55 to 89) to test if a new drug, bapineuzumab, will slow down the progression of Alzheimer’s. Dr. Yadalam is a MD, a Certified Physician Investigator and Medical Director of Lake Charles Clinical Trials.
“It is important to state clearly that bapineuzumab may slow the disease process in Alzheimer’s, but whether it can help more remains to be seen” said Dr. Yadalam.

The trial lasts thirteen months with an optional follow-up treatment and it involves extensive assessment of cognitive function (memory, reasoning, judgment, etc) along with frequent MRIs of the brain. The participant and the caregiver are asked questions at each visit to assess the progress of treatment.

In 1987, Dr. Yadalam was part of a team that conducted the first drug study in Alzheimer’s. His previous research experience at the Medical College of Pennsylvania in Philadelphia is the reason why Lake Charles was chosen as a site (among many others across the country and the globe) to conduct the study.

Alzheimer’s is often misunderstood. Dr. Yadalam uses the following example to explain some of the common misconceptions involved with Alzheimer’s. “Say someone has a cough. The cause of the cough could be anything from a mild infection to even cancer. The cough alone doesn’t tell you what the disease is, it is a symptom,” said Dr. Yadalam. “Similarly, dementia is a syndrome i.e., a collection of symptoms, such as, short-term memory loss, confusion, language problem, and even aggression. Many have dementia, but not everybody who has dementia has Alzheimer’s. It is not possible to diagnose the type of dementia just by talking to the patient” said Dr. Yadalam.
There are two ways to diagnose Alzheimer’s: the definitive diagnosis is by examining a sample of brain tissue (upon death) or by doing a PET-scan. These scans are very expensive, so the physicians diagnose most often by blood tests, MRI of the brain and disease exclusion.

“The cause of this disease is not known yet but, many brain abnormalities have been identified. A prominent abnormality is the accumulation of a protein called beta-amyloid” said Dr. Yadalam. Currently, it is not known if there is an increased production of beta amyloid or if the affected brain is less efficient in eliminating this protein.

“Bapineuzumab, the compound we are testing, aims to remove amyloid from the brain thereby relieving the adverse effect it has on the brain. We will know more about its overall effectiveness once the trial has been completed at all sites and the data analyzed. Hopefully, we are getting closer to reaching our goal.” said Dr. Yadalam.

The treatment is a double-blind study, meaning that some patients receive a placebo, while others receive the drug. Neither patient nor Dr. Yadalam knows what each patient receives. This protects the study from being compromised.

Sharon Garrett, Mary Long, and Therese Novak along with other staff work with Dr. Yadalam in this study at this research facility. “Assessments, cognitive testing and dependence scales are administered to understand the extent of the disease,” said Garrett. “We also rely on caregiver questionnaires,” said Long.

“The double-blind portion of the trial lasts thirteen months. During this period they receive six intravenous infusions of bapineuzumab and undergo MRIs six times. Each visit we spend a lot of time assessing their level of functioning using various standardized rating scales and we also ask caregivers detailed questions about their observations. As you can see, we spend a lot of time with them and they are monitored very closely,” said Dr. Yadalam.

“During the course of this trial, we learned that people who have the Alzheimer’s gene require a different treatment approach than non-carriers of the gene. This distinction is not made in current clinical practice.” said Dr. Yadalam. People who are carriers of the disease receive a lower dose of the drug than non-carriers because when given an identical dose of this compound, the carriers suffer greater and more severe side effects. Dr. Yadalam identifies the carriers by conducting a genetic test. “We take a blood sample and send it for testing. If the APO-E4 gene is found then they are carriers,” said Dr. Yadalam.

Dr. Yadalam said that some patients may have side effects from the drug such as confusion and worsening of symptoms. “When the protein is removed from the brain some suffer a microscopic bleed which can be seen by MRI but most patients don’t have any symptoms.” said Dr. Yadalam. “But, microscopic bleeding is sometimes seen in patients who are not even receiving any treatment. That is why we need to conduct these studies to identify what is causing these problems,” said Dr. Yadalam.

Participation in the treatment program does not cost anything. Caregivers must be willing to bring in the patients and participate in the assessments to rate the patients. Patients and caregivers participating in the trial are reimbursed for their time and travel and transportation is provided to those who have no means.

Although there is no cure currently, hopefully this study being conducted in Lake Charles Clinical Trials will lead to future discoveries in Alzheimer’s treatment.

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