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Thursday, September 24, 2020

FDA Approves First Drug to Be Used as Tool for Diagnosing Alzheimer’s

Butler Hospital picked as study site for new drug

Memory and Aging Program News

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

Study: Amyloid Plaques in Brain Linked to Greater Growth of Tau “Tangles,” Development of Alzheimer’s