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

NCT06058234 | Recruiting FDA Drug

• 1 other identifier: 99999999
• Study Type: observational
• Target: 8,680
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

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

Study Sites (1)

Centers for Medicare and Medicaid Services

Baltimore, Maryland, 21244, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

CMS CAG

CONTACT

410-786-2281; CMS_caginquiries@cms.hhs.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 28, 2023
• Study Start: July 6, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)