RecruitingNCT06058234

Medicare Anti-Aβ mAb Coverage With Evidence Development (CED) Study

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)


Sponsor

Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

Enrollment

8,680 participants

Start Date

Jul 6, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Inclusion Criteria1

  • 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 Criteria1

  • none

Interventions

DRUGMonoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease

FDA approved monoclonal antibodies directed against amyloid for the treatment of AD


Locations(1)

Centers for Medicare and Medicaid Services

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT06058234


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