Phase 3 Trial Results Suggest Flortaucipir Tracer Agent Can Help Predict Alzheimer’s Diagnosis
Flortaucipir, an investigational imaging agent, was able to efficiently detect Tau protein aggregates and related Alzheimer’s disease brain changes, meeting both of its primary objectives in a Phase 3 trial.
Results of the trial revealed that flortaucipir demonstrated great sensitivity in identifying tau-related damage and predicting Alzheimer’s disease diagnosis.
“These encouraging results are a major advance in our ability to image the pathology of Alzheimer’s disease,” Mark Mintun, MD, vice president of pain and neurodegeneration research and development at Eli Lilly and Company, said in a press release.
Flortaucipir, also known as [F-18]T807 or 18F-AV-1451, is a radiolabeled positron emission tomography (PET) tracer agent being developed by Avid Radiopharmaceuticals, a wholly owned subsidiary of Lilly. It was designed to specifically detect abnormal Tau protein aggregates, which are important contributors to the development and progression of several neurological conditions, including Alzheimer’s disease.
This investigational tracer has shown a 25 times higher selectivity for tau over beta-amyloid tangles, another type of toxic protein aggregate often present in Alzheimer’s disease.
Compared with other tau-targeted tracers being developed, flortaucipir was more specific and efficient in determining tau-related Alzheimer’s disease status with reduced off-target (non-specific) binding.
The open-label Phase 3 A16 study (NCT02516046) enrolled 156 patients with dementia, mild cognitive impairment, or normal cognition, who had a life expectancy of six months or less. Participants consented to donate their brain for autopsy assessment, and 67 of the patients were evaluated post-mortem.
Participants received a single injection of the radiolabeled agent and underwent PET imaging of their brains.
The results revealed that flortaucipir had a statistically significant sensitivity and specificity for detecting tau-related distribution patterns and consequent disorder with extensive brain involvement. The tracer agent could also detect, with a high degree of specificity and sensitivity, total Alzheimer’s-related brain changes, including both tau and amyloid plaque burden.
“We hope this and other advances in the field can help speed development of treatments, as well as provide more diagnostic information for doctors taking care of patients suspected of having Alzheimer’s,” Mintun said.
The company is planning to present more detailed data of the A16 study at the 11th Clinical Trials on Alzheimer’s Disease meeting in October in Barcelona, Spain. During the meeting, the company is going to discuss the trial’s findings and potential next steps with the U.S. Food and Drug Administration.