Health TrialsbyHealthPanel

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

ConditionsMild Alzheimer's DiseaseMild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCenters for Medicare and Medicaid Services/ Coverage and Analysis Group

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

none

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Change in cognition

Cognition measured by the Montreal Cognitive Assessment (MoCA©) (score ranges from 0 to 30; higher scores are generally better).

Time frame
24 months
2

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).

Time frame
24 months
3

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).

Time frame
24 months
4

Change in function

Function as measured by the Functional Activities Questionnaire (FAQ) (scores range from 0 to 30; lower scores are generally better).

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centers for Medicare and Medicaid Services/ Coverage and Analysis Group

Lead sponsor

Source ClinicalTrials.gov
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