Amyloid PET

Positron Emission Tomography (PET) is a minimally-invasive diagnostic imaging procedure used to distinguish normal from diseased tissue in conditions such as cancer, ischemic heart disease, and some neurologic disorders.  In amyloid PET imaging, a ligand that binds to a given targeted substrate (e.g., Aβ plaque aggregates) is labeled with a radioisotope (e.g., fluorine F18). The injected radiopharmaceutical (or “tracer”) emits positrons when it decays. PET uses a positron camera (tomograph) to measure the decay of such tracers within human tissue. The injected radiopharmaceutical emits positrons when it decays. PET uses a positron camera (tomograph) to measure the decay of such tracers within human tissue. The relative differences in the rate of tracer decay among anatomic sites provide biochemical information on the tissue being studied. Amyloid PET imaging uses a class of radiopharmaceuticals that detect levels of amyloid in the human brain.  Examples of these radiopharmaceuticals include Amyvid™ (florbetapir F18), Neuraceq™ (florbetaben F18) and Vizamyl™ (flutemetamol F18).   Measurements of cerebral amyloid may be clinically useful in the work up and management of patients with cognitive impairment who are being evaluated for possible Alzheimer's disease or other causes of cognitive decline.

CMS issued a Medicare National Coverage Determination (NCD) on September 27, 2013 which allows conditional coverage of amyloid PET under Coverage with Evidence Development (CED).  The complete NCD is available on our website.

Decision Memo
 

 Below is a list of Medicare-approved clinical trials we have reviewed and determined meet the requirements for coverage under CED.

Clinical Study Approvals

Study Title: Prospective Study on Anti-Amyloid-β Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease Coverage of Evidence Development (The Anti-Aβ mAb CED Study)
Clinicaltrials.gov number: To be announced
Temporary Clinical Trial # “99999999”
Study Description/Summary (PDF)
CMS Approval Date: 07/06/2023

Study Title: A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Sponsor: Beth Israel Deaconess Medical Center
Clinicaltrials.gov number: NCT05925621
CMS Approval Date: 07/11/2023

Study Title: New IDEAS: Imaging Dementia-Evidence for Amyloid Scanning Study
Sponsor: American College of Radiology
ClinicalTrials.gov Number: NCT04426539
CMS Approval Date: 4/21/2020

Study Title:  Cognitive Training and Practice Effects in MCI
Sponsor:  University of Utah
ClinicalTrials.gov Number:  NCT02301546
CMS Approval Date:  01/05/2016

Study Title: Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study
Sponsor: American College of Radiology Imaging Network
ClinicalTrials.gov Number:  NCT02420756  
IDEAS Study site: http://ideas-study.org/  
CMS Approval Date:   03/03/2015

Study Title: Effect of Aerobic Exercise on Pathophysiology in Preclinical Alzheimer’s Disease
Sponsor: National Institute on Aging
ClinicalTrials.gov Number: NCT02000583
CMS Approval Date: 04/02/2014