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

• ClinicalTrials.gov Identifier: NCT06058234
• Recruitment Status: Recruiting
• First Posted: September 28, 2023
• Last Update Posted: September 28, 2023
• Sponsor: Centers for Medicare and Medicaid Services/ Coverage and Analysis Group
• Information provided by (Responsible Party): Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

Study Description

Brief 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).

Condition or disease	Intervention/treatment
Mild Alzheimer's Disease; Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease	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 Design

• Study Type: Observational
• Estimated Enrollment: 8680 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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)
• Actual Study Start Date: July 6, 2023
• Estimated Primary Completion Date: June 30, 2028
• Estimated Study Completion Date: June 30, 2029

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: CMS CAG; 410-786-2281; CMS_caginquiries@cms.hhs.gov

Locations

United States, Maryland

Centers for Medicare and Medicaid Services; Recruiting

Baltimore, Maryland, United States, 21244

Contact: CMS CAG 410-786-2281 CMS_caginquiries@cms.hhs.gov

Sponsors and Collaborators

Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

More Information

Additional Information:

medicare National Coverage Determination 

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

Study Description 

• Responsible Party: Centers for Medicare and Medicaid Services/ Coverage and Analysis Group
• ClinicalTrials.gov Identifier: NCT06058234
• Other Study ID Numbers: 99999999
• First Posted: September 28, 2023
• Last Update Posted: September 28, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Alzheimer Disease; Cognitive Dysfunction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Antibodies; Antibodies, Monoclonal; Immunologic Factors; Physiological Effects of Drugs