Transcript Mr. Eric Sokol, Senior Vice President

HOW IMAGING IMPACTS
DIAGNOSIS AND DRUG
DEVELOPMENT FOR
ALZHEIMER’S DISEASE
Three Factors Driving Alzheimer’s
Policy
• Incidences are increasing
– Aging of the baby boomers
– 4.7 million with AD in 2010; 13.8 million by 2050
• Costs are skyrocketing and not sustainable
– Direct care costs were $109 billion in 2010
– $159 - $215 billion when calculating paid and family
caregivers
• Only disease in top 10 causes of death with no
cure or modifying treatment
– CDC’s 6th leading cause of death in the US
– Only growth category in top 10
IMAGING FOR ALZHEIMER’S
• PET Imaging
– Alzheimer's imaging agents are radiotracers capable of detecting betaamyloid and tau proteins in the brain
– Tracers it can be visualized during a positron emission tomography
(PET) brain scan
– Amyloid and tau are both pathological hallmarks of Alzheimer's
disease
– Only method currently approved by FDA
• MRI arterial spin labeling (ASL-MRI)
– changes in blood flow
– uptake of blood sugar, or glucose
– Could detect earliest stages of pre-symptomatic Alzheimer’s
• 3-D image mapping of brain
– Compares size of hippocampus and other parts of the brain
IMAGING USE AS DIAGNOSTIC TOOL
• Benefits of early and proper detection of Alzheimer’s disease are
many and varied:

inform family members, friends, and caregivers of diagnosis;

make living arrangements;

address financial and legal matters;

express end-of-life wishes;


adopt healthy lifestyles (i.e., proper diet, mental activity, physical
exercise);

take advantage of support services; and

develop care teams and other support networks.
PET scan can be used to exclude Alzheimer’s in difficult cases where
misdiagnosis can be counter to effective treatment
USE IN CLINICAL TRAILS
• FDA focus on new Alzheimer’s drug development
is stopping progression in early stages of the
disease
• Requiring clinical trial participants to be presymptomatic or early stages of disease
progression
• PET imaging tool to identify the ideal participants
for such clinical trial that’s essential for
Alzheimer’s disease drug development.
RECOMMENDATIONS FOR IMAGING IN
THE ALZHEIMER’S SPACE
• Imaging needs to be fully integrated into any Alzheimer’s disease
treatment plan
• Critical tool to confirm a diagnosis of Alzheimer’s disease and can
play a significant role in ensuring effective care management,
enabling appropriate planning and improving health outcomes.
– Medicare should cover screens for appropriate populations:
• Persons with persistent or progressive unexplained MCI
• Persons satisfying core clinical criteria for possible AD but have unclear
clinical presentation
• Young onset (65 years or less in age)
• Crucial to Alzheimer’s drug development by identifying presymptomatic populations
– Most valuable in clinical trials
– Medicare coverage should extend for all screens for those enrolled in
clinical trials
Questions?
• Contact information:
Eric Sokol, AFA’s VP of Public Policy
202-462-3510
[email protected]