Medicare Study on Monoclonal Antibodies for Alzheimer's Disease

This study is looking at how well FDA-approved monoclonal antibodies directed against amyloid work for people with mild Alzheimer's disease or mild cognitive impairment (MCI) due to Alzheimer's. These medications target amyloid, a protein thought to be involved in Alzheimer's. You could be eligible if you are a Medicare patient with a diagnosis of mild Alzheimer's or MCI due to Alzheimer's, and tests confirm you have amyloid beta pathology. Researchers will track changes in your thinking (cognition) and daily function over 24 months to see how these medications impact your condition. The study aims to enroll 8,680 participants.

Study design
This is an observational study, meaning researchers will watch and collect information about participants receiving treatment. It plans to include 8,680 participants.
What's involved
You would have a neurocognitive evaluation and biomarker testing to confirm your diagnosis. Your prescribing doctor will assess your cognition and function every six months for up to 24 months, submitting this data to a registry.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months, with assessments every six months.

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NCT06058234

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

Recruiting
Not specifiedAll AgesObservational
Centers for Medicare and Medicaid Services/ Coverage and Analysis Group
~8,680 participants
Updated 2023-09-28 on ClinicalTrials.gov
What's tested:Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in cognition
Measured over 24 months
+4 more outcomes measured
Mild Alzheimer's Disease
Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
1 sites across 1 states
Maryland1

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Eligibility criteria

Inclusion

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

none
  • Change in cognition24 months

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

  • Change in cognition24 months

    Cognition as measured by global Clinical Dementia Rating (CDR) (each of six domains ranges from 0 to 3; lower scores are generally better).

  • Change in function24 months

    Function as measured by global Clinical Dementia Rating (CDR) (each of six domains ranges from 0 to 3; lower scores are generally better).

  • Change in function24 months

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

  • Adverse Events (Harms)24 months

    Incidence of adverse events such as amyloid related imaging abnormalities (ARIA), stroke, infections.