Alzheimer’s is the most common cause of dementia in the elderly, affecting 18 million worldwide and 5 million in the United States alone. No cure has been found for this disease, but participants are being sought to try a new drug aimed at slowing its progression.
“There are five approved medications for Alzheimer’s disease, but they only lessen the severity of the symptoms and make mental faculties operate a little bit better,” said Dr. Lawrence Honig, lead investigator of the clinical trial at Columbia University. The result is an “apparent slowing down” of the disease.
“We are working very hard to investigate drugs that we hope will influence the disease process,” he said, a “true slowing down.”
The ICARA study (which stands for “Investigational Clinical Amyloid Research in Alzheimer’s”), commonly called the “Bapi” study—after Bapineuzumab, the name of the drug being tried—will last roughly 18 months. The drug will be administered six times intravenously and may help clear a protein that accumulates in brain tissue to form the plaques believed to play a major role in the development of Alzheimer’s disease.
Researchers are screening 50- to 88-year-olds with mild to moderate Alzheimer’s for eligibility.
“We’re not enrolling people who are severe for two primary reasons,” Honig said. “It’s better to modify it earlier rather than later, and it’s hard to measure function in people with severe disease because they must be able to complete paper and pencil tests.”
Participants need to be living in the community, not a rest home or nursing care facility, and they must have a reliable caregiver or relative who can accompany them to all 15 study visits and answer questions.
“We encourage people to step forward,” Honig said.
All study-related drugs and tests are paid for by the study, sponsored by Elan Pharmaceuticals, Inc., and participation is free.
“Participants generally develop a close relationship with the doctors and nurses who coordinate the study,” Honig said.
Sixty percent will get the new drug and 40 percent will be randomly chosen to receive a placebo. If the drug is found to be effective, however, “Everyone gets the real thing.” Blood tests and physical and clinical exams will be administered in addition to the six drug or placebo infusions.
The “Bapi” study will be taking place at numerous sites throughout the country. Here in New York City, the sites are Columbia University, New York University School of Medicine and Mt. Sinai.
To find out more call 877-797-8839 (note: When you call the study may be referred to as the “Elan Alzheimer’s Study”) or visit www.icarastudy.com.
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