Butler Hospital picked as study site for new drug
Tau
PET Detects AD Dementia. AD patients (left) accumulate tau tangles throughout
the brain. [Courtesy of Ossenkoppele et al., ©2018, American Medical
Association. All rights reserved.]
The U.S. Food and Drug Administration (FDA) has approved Tauvid (flortaucipir F18) for intravenous injection as the first drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology.
The approval comes one month after publication of the results of the national A16 study, which showed that Positron Emission Tomography (PET) imaging used in combination with flortaucipir tracer was successful in confirming the presence of tau protein in the brain, helping to establish an Alzheimer’s diagnosis in patients suspected of having the disease.
Butler Hospital was
one of 27 study sites across the U.S. to participate in the study, through a
partnership between its Memory and Aging Program, which facilitated the study
and Rhode Island Hospital, which conducted the imaging.
“We are so proud to have partnered with Rhode Island Hospital to be part of this major advance in the diagnosis and treatment of Alzheimer’s disease and we’re deeply appreciative of our courageous study participants who made this happen,” said Dr. Stephen Salloway, Director of the Memory and Aging Program at Butler Hospital. Dr. Salloway was also one of the authors of the A16 study and a lead study clinician through all phases of the development of the flortaucipir tracer.
The A16 study was made possible by the selfless participation of terminally ill patients who agreed to donate their brains to science after death. Participants were all 50 years old or older with a diagnosed terminal illness and projected life expectancy of less than 6 months.
All agreed to participate in PET imaging
and to then donate their brain to science after their death for the purpose of
postmortem examination. Changes in the brain found upon autopsy were compared
to the results indicated by the scans.
Results
showed that PET imaging with flortaucipir provides significant sensitivity and
specificity for detecting tau protein in the brain. These results were
confirmed by a second set of independent physician readers of the PET scans in
a follow-up validation study. The study also showed that the use of
flortaucipir was safe, with relatively few adverse effects among patients.
The
study’s authors concluded that in appropriate clinical cases of adults who have
undergone adequate neurological assessment and have been evaluated for
Alzheimer’s disease or other causes of cognitive decline, PET imaging with
flortaucipir may help in establishing a diagnosis of Alzheimer’s, and that
further research is required into the potential value of flortaucipir imaging
in earlier stages of the disease.
Associate
Director of the Alzheimer’s Disease and Memory Disorders Center at Rhode Island Hospital,
Dr. Jonathan Drake said, "The announcement by the FDA regarding approval of
tau-PET imaging for Alzheimer’s disease in the clinic is a major advancement
for the field. We know that tau protein buildup in the brain is one of the main
drivers of Alzheimer’s disease, which begins long before the first symptoms of
memory loss occur. A longstanding goal of the field has been to develop
techniques for detecting tau at its earliest stages and developing strategies
for preventing disease progression, so this news is indeed very exciting.”
“The participants of this study were incredibly selfless in their contribution to furthering Alzheimer’s research,” Dr. Salloway said. “The build-up of tau tangles in the brain is a key cause of Alzheimer’s disease and the development of tau PET is a milestone achievement. Thanks to our valiant study participants, we now have a new tool to accurately diagnose Alzheimer’s disease.”
Related
Resources
Learn more about research studies at
the Memory and Aging Program at Butler Hospital
Study Points to Possible
New Tool for Diagnosis of Alzheimer’s
