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The Clinical Need

The American population is aging.  Currently 39 million people in America (12.8%) are over 65 years old.  This number is expected to increase.

Today 7% of people over 60 years old have some kind of neuro-degenerative illness, such as Alzheimer’s disease (AD), mild cognitive impairment (MCI), frontal-temporal dementia (FTD), and Parkinson’s disease.  A PET scan will be used in 10% of this affected population as part of the patient care algorithm.

Further research is showing that early and perhaps pre-symptomatic diagnosis of Alzheimer’s disease (such as with PET/CT imaging) coupled with early intervention may be essential to effective treatment.

The Approaching Opportunity

Significant emerging developments in the treatment and diagnosis of Alzheimer’s disease will strongly influence increased adoption of the neurological application of PET. These developments include

  1. the development of therapeutic drug treatments for Alzheimer’s,
  2. the use of PET imaging as a research biomarker in Alzheimer’s drug development, and
  3. the use of validated PET biomarkers for the early detection of Alzheimer’s disease.

Today there are several potential treatments for Alzheimer’s disease in Phase 2 and Phase 3 FDA clinical trials.  PET scanning is being used as a key tool in the development of these treatments.  Alzheimer’s is traditionally diagnosed at death by the presence of beta amyloid plaques and neurofibrillary tangles of tau amyloid in the brain at autopsy. Use of PET biomarkers is seen by the FDA and the research community as one of the key tools in the research on these treatments. In July 2010 Avid Radiopharmaceuticals announced the complete results from its phase 3 clinical trial with 100% accuracy.  Other radiotracers from GE and Bayer are also in phase 3 trials.

These new radiotracers are labeled with F18 and will be amenable to commercial distribution by regional radiopharmacies, just as it is done with Fluoro-deoxy Glucose (FDG) today.

The situation is similar with Parkinson’s disease with both diagnostic PET biomarkers (e.g. AV133 and other dopaminergic compounds) and treatments moving through the FDA process.

Clinical scanning for Alzheimer’s disease with FDG is reimbursed by insurance currently with some restrictions on pre-scanning clinical workup.