Centers for Medicare and Medicaid Services/ Coverage and Analysis Group
The Anti-Aβ mAb CED Study is a prospective, longitudinal coverage with evidence development (CED) study using clinical data, patient assessments, and administrative claims data of the Medicare population, conducted in accordance to the National Coverage Determination (NCD) on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD).
The Anti-Aβ mAb CED Study is conducted in accordance with the coverage criteria specified in the NCD for patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia. The complete NCD decision memorandum is available on our website (https://www.cms.gov/medicare-coverage-database/view/ncacal-decisionmemo.aspx?proposed=N\&ncaid=305). Study Overview: 1. Clinicians will conduct a neurocognitive evaluation to determine patient eligibility by confirming a clinical diagnosis of MCI due to AD or mild AD dementia, and the presence of amyloid using biomarker…
Inclusion Criteria: * Medicare patients with a clinical diagnosis of mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD. Exclusion Criteria: * none
FDA approved monoclonal antibodies directed against amyloid for the treatment of AD
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