Eli Lilly and Company has presented the new data demonstrating that knowledge of amyloid status as specified by Florbetapir F 18 Injection imaging, altered diagnosis and management in the majority of patients being studied.
The multicentre trial was designed to assess the impact of amyloid positron emission tomography (PET) on patient management and outcomes in a randomised and controlled setting.
Presented along with its subsidiary Avid Radiopharmaceuticals, the results also demonstrated that knowledge of amyloid status as determined by florbetapir imaging changed patient management in the majority of study patients, specifically Alzheimer's disease medications, in a direction consistent with amyloid status.
Avid Radiopharmaceuticals clinical development vice-president Dr Michael Pontecorvo said: "These study results are the first to suggest in a controlled study that adding florbetapir to the diagnostic evaluation changed actual patient diagnosis and management by physicians who regularly manage this complicated and devastating disease."
Using the randomised and controlled prospective design, the study observed the impact of amyloid imaging on diagnosis and actual patient management.
Physicians recorded a working diagnosis and management plan, after identifying patients seeking diagnosis for mild impairment or dementia, where Alzheimer's disease was considered a possible cause.
The patients later completed a florbetapir PET scan and were then randomised to either immediate or delayed (one year) feedback groups regarding amyloid status.
In the study, the firms randomised 618 subjects to the immediate (308) or to the delayed (310) amyloid PET feedback arms, comprising 174 subjects in France, 221 in Italy, and 223 in the US.
The 602 subjects completed the three-month and 560 completed the one-year follow-up visits.