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

Last updated: September 21, 2023
Sponsor: Centers for Medicare and Medicaid Services/ Coverage and Analysis Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Memory Problems

Dementia

Treatment

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

Clinical Study ID

NCT06058234
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  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Medicare patients with a clinical diagnosis of mild cognitive impairment due toAlzheimer's disease (AD) or mild AD dementia, both with confirmed presence of amyloidbeta pathology consistent with AD.

Exclusion

Exclusion Criteria:

  • none

Study Design

Total Participants: 8680
Treatment Group(s): 1
Primary Treatment: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease
Phase:
Study Start date:
July 06, 2023
Estimated Completion Date:
June 30, 2029

Study Description

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&ncai d=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 testing including imaging (amyloid PET), cerebral spinal fluid (CSF) studies, and/or blood tests.

  2. For all Medicare beneficiaries receiving anti-Aβ mAb treatment for MCI due to AD or mild AD dementia, the prescribing clinician will assess the patient's baseline clinical status by cognition and function assessments using validated tools appropriate for use in the MCI with AD and mild AD dementia populations and submit these data to the registry via the dedicated CMS CED submission portal every six months for up to 24 months (five total assessments).

  3. In addition to performing the required cognition and function assessments, prescribing clinicians will need to report on the patient's use of anti-platelet and/or anti-coagulation therapy and whether the patient has developed new amyloid related imaging abnormalities (ARIA) since the last assessment data submission.

Connect with a study center

  • Centers for Medicare and Medicaid Services

    Baltimore, Maryland 21244
    United States

    Active - Recruiting

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