Neurological Care of CNY is a test site for new Alzheimer drug

The new drug trial by Elan Pharmaceuticals is ICARA or Investigatational, Clinical, Amyloid, Research in Alzheimer. It is also commonly known as the Bapi study, which is evaluating the safety and effectiveness of a new drug, bapineuzamab ,which involves a new approach to dealing with Alzheimer Disease (AD).

There is still no known cure, but this drug is aimed at slowing down the disease progression and will be used in tandem with the current Alzheimer drugs on the market Aricep (Exelon, Razadyne) and Namenda.

There are 200 trial sites around the United States and Canada with one in CNY. Dr. Smita Kittur of Nuerologial Care of Central New York in Syracuse has been selected to test 16 patients. There are already eight enrolled in the trial.

- The new drug is an antibody to the amyloid protein, which when given by Intravenous infusion, will attach itself to the amyloid,¡± Kittur said.

It is hoped that it will then remove the amyloid from the cell, and will also prevent the development of further amyloid proteins forming within that cell.

- They found in mice that it removed the already deposited protein and helped to prevent the progression,¡± she said.

Kittur said, when people talk about memory problems or dementia, 90 percent is AD. Non-AD-dementia could be caused by a problem with B12 absorption, stroke or an aneurysm.

"The patient interested in inclusion in this trial will be evaluated for Alzheimer¡¯s Disease by performing a memory or psychological test,¡± Kittur said. ¡°And also, a blood test and MRI, which is mainly to rule out other diseases.¡±

She said this drug differs greatly from Aricep, Exelon or Razadyne, which all work the same by helping to maximize brain activity. And, also the latest drug on the market, Namenda, is more for protection of the brain cells caused by calcium that grows inside the cells.

- When we learn something new, at that time a channel opens inside the brain cell and not close, which will result in a flood of calcium,¡± Kittur said.

- These are better than not taking anything,¡± she said and will be continued during the trial.

The current medications are mostly aimed at maximizing the brain activity; The ICARA study is evaluating the safety and effectiveness of a new drug aimed at slowing down the disease progression and possibly even helping with prevention.

The conditions of the trial include:
- A caregiver must be present at all treatments.
- Participant between the ages of 50 and 88.
- Must pass a test that determines presence of AD.
- Damage to the brain, such as a stroke or an aneurysm ¨C will disqualify the patient.
- Other significant neurological disease or major psychiatric disorder will disqualify the patient.
- Persons interested in the study will remain on their current AD medications throughout.
- There is a 60-percent chance of receiving the drug and a 40-percent chance of receiving a placebo.
- A woman can not be of childbearing potential

How can participants benefit?
Clinical research is necessary to determine whether this new drug works and if it is safe. There is no guarantee, but the information gathered from this study could help future AD patients.
¡ñ Participants will receive the investigational drug, physical exams, as well as laboratory services and tests. Throughout the study, participants will be monitored by a medical team including a nurse (or study coordinator) and a physician.

What the trial will entail?
- There will be no charge to participate.
- The procedure is a 45 minutes infusion, for a total of six times with 13 weeks in between each infusion.
- There is also a four-hour monitoring of the patient immediately following the first infusion and then two-hour monitoring at the subsequent five infusions.
- Because this is an antibody, the doctor is making sure there isn¡¯t a negative reaction during the monitoring period. If there is an immune system reaction, she has drugs to counteract this, but also the patient will not be allowed to continue.

Those interested in participating should call 701-4554. For more information visit or call 1-888-770-6366 (memory).

Alzheimer disease facts:
- There is no current cure for AD
- 90 percent of all dementia is AD.
- One in two people by age 85 will have AD.
- More than 5 million people in the US have been diagnosed.
- The national annual cost is $1,000,000,000.
- Typically a patient can cost a household up to $36,000 a year.

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