Recruiting

Anti-Aβ mAb

Sponsor:

Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

Code:

NCT06058234

Conditions

Mild Alzheimer's Disease

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

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06058234

Start date

Jul 6, 2023

Status verified date

Sep, 2023

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

8680 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

FDA approved monoclonal antibodies directed against amyloid for the treatment of AD

Primary outcome measure

  • Change in cognition [ Time Frame: 24 months ]
  • Change in cognition [ Time Frame: 24 months ]
  • Change in function [ Time Frame: 24 months ]
  • Change in function [ Time Frame: 24 months ]
  • Adverse Events (Harms) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

CMS CAG

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

Locations

Centers for Medicare and Medicaid Services

Recruiting

Baltimore, Maryland, United States, 21244

Contacts

CMS CAG

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

More Information

Sponsor

Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centers for Medicare and Medicaid Services/ Coverage and Analysis Group on 2023-09-28.