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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Centers for Medicare and Medicaid Services/ Coverage and Analysis Group
Study ID
NCT06058234
Status
Recruiting

Conditions

  • Mild Alzheimer's Disease
  • Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease — DRUG
    FDA approved monoclonal antibodies directed against amyloid for the treatment of AD

Study Details

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).

Key Dates

Start date
Jul 6, 2023
Status verified
Sep 2023
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
8,680 participants (estimated)

Primary Outcome Measure

Change in cognition [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Centers for Medicare and Medicaid ServicesBaltimoreMaryland21244
CMS CAG
410-786-2281

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