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

Mild Alzheimer's Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058234
• Other study ID #: 99999999
• Status: Recruiting
• Start date: July 6, 2023
• Est. completion date: June 30, 2029

Study information

• Verified date: September 2023
• Source: Centers for Medicare and Medicaid Services/ Coverage and Analysis Group
• Contact: CMS CAG
• Phone: 410-786-2281
• Email: CMS_caginquiries[@]cms.hhs.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8680
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
United States	Centers for Medicare and Medicaid Services	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognition	Cognition measured by the Montreal Cognitive Assessment (MoCA©) (score ranges from 0 to 30; higher scores are generally better).	24 months
Primary	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
Primary	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
Primary	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
Primary	Adverse Events (Harms)	Incidence of adverse events such as amyloid related imaging abnormalities (ARIA), stroke, infections.	24 months

External Links

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