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)

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).

Study Overview

• Status: Recruiting
• Conditions: Mild Alzheimer's Disease; Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
• Intervention / Treatment: Drug: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease

Detailed 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&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 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.

• Study Type: Observational
• Enrollment (Estimated): 8680

Contacts and Locations

• Study Contact: Name: CMS CAG; Phone Number: 410-786-2281; Email: CMS_caginquiries@cms.hhs.gov

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21244
      • Recruiting
      • Centers for Medicare and Medicaid Services
      • Contact: CMS CAG; Phone Number: 410-786-2281; Email: CMS_caginquiries@cms.hhs.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognition	Cognition measured by the Montreal Cognitive Assessment (MoCA©) (score ranges from 0 to 30; higher scores are generally better).	24 months
Change in cognition	Cognition as measured by global Clinical Dementia Rating (CDR) (each of six domains ranges from 0 to 3; lower scores are generally better).	24 months
Change in function	Function as measured by global Clinical Dementia Rating (CDR) (each of six domains ranges from 0 to 3; lower scores are generally better).	24 months
Change in function	Function as measured by the Functional Activities Questionnaire (FAQ) (scores range from 0 to 30; lower scores are generally better).	24 months
Adverse Events (Harms)	Incidence of adverse events such as amyloid related imaging abnormalities (ARIA), stroke, infections.	24 months

Collaborators and Investigators

• Sponsor: Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

Publications and helpful links

Helpful Links

• medicare National Coverage Determination
• Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease CED Study Registry
• Study Description

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: 99999999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No