لخّصلي

In January, an expert advisory panel of the FDA debated whether florbetapir was
ready for marketing. The group did not suggest that the FDA approve the drug at
this time. Still, the experts said they made the judgment based on available
information. And they asked for more information. They also set conditions for
accepting florbetapir. One condition is for the manufacturer to show evidence that florbetapir correctly
identifies plaques. The other condition is that the manufacturer prepare a training
program for experts in nuclear medicine. The advisory panel said the doctors reading
the test need additional education to correctly identify the plaques. The Food and Drug Administration will decide next month whether to accept the
panel’s suggestions. The FDA normally follows the advice of its expert advisers, but
not always. If it is approved, florbetapir would be the first agent permitted to measure plaque
deposits in living patients. Still, the presence of plaques does not prove that a patient
has Alzheimer’s disease. Doctors say some people with amyloid plaques in their
brains do not have the condition. An estimated thirty million people around the world have Alzheimer’s disease. In
the United States alone, more than five million people suffer from this presently
incurable brain disorder. Alzheimer’s affects memory and personality -- those qualities that make a person an
individual. At first, people with the condition forget simple things, like where they
left the keys to their car. But as time passes, they forget more and more. They may
forget what a key is used for. Patients forget the names of their husbands, wives or children. Then they forget who
they are. Finally, they remember almost nothing. It is as if their brains die before the other
parts of the body. Victims of Alzheimer’s do die from its effects or conditions linked
to it. But death may not come for many years. Dementia is the loss of thinking ability that is severe enough to interfere with daily
activities. It is not a disease itself. Instead, dementia is a group of signs of some
conditions and diseases.

In January, an expert advisory panel of the FDA debated whether florbetapir was

ready for marketing. The group did not suggest that the FDA approve the drug at

this time. Still, the experts said they made the judgment based on available

information. And they asked for more information. They also set conditions for

accepting florbetapir.
One condition is for the manufacturer to show evidence that florbetapir correctly

identifies plaques. The other condition is that the manufacturer prepare a training

program for experts in nuclear medicine. The advisory panel said the doctors reading

the test need additional education to correctly identify the plaques.
The Food and Drug Administration will decide next month whether to accept the

panel’s suggestions. The FDA normally follows the advice of its expert advisers, but

not always.
If it is approved, florbetapir would be the first agent permitted to measure plaque

deposits in living patients. Still, the presence of plaques does not prove that a patient

has Alzheimer’s disease. Doctors say some people with amyloid plaques in their

brains do not have the condition.
An estimated thirty million people around the world have Alzheimer’s disease. In

the United States alone, more than five million people suffer from this presently

incurable brain disorder.
Alzheimer’s affects memory and personality -- those qualities that make a person an

individual. At first, people with the condition forget simple things, like where they

left the keys to their car. But as time passes, they forget more and more. They may

forget what a key is used for.
Patients forget the names of their husbands, wives or children. Then they forget who

they are.
Finally, they remember almost nothing. It is as if their brains die before the other

parts of the body. Victims of Alzheimer’s do die from its effects or conditions linked

to it. But death may not come for many years.
Dementia is the loss of thinking ability that is severe enough to interfere with daily

activities. It is not a disease itself. Instead, dementia is a group of signs of some

conditions and diseases.