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NCT Number: NCT06058234

Medicare Anti-Aβ mAb Coverage With Evidence Development (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).

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Key information

Conditions

Mild Alzheimer's Disease Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Centers for Medicare and Medicaid Services

Baltimore, Maryland, 21244, United States

Location status: Recruiting

Location contact

CMS CAG

CONTACT

[email protected]

410-786-2281

About this study

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:

  • 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.
  • 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).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

CMS CAG

CONTACT

[email protected]

410-786-2281

Sponsors and collaborators

Lead sponsor

Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

Fed

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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