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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Medicare Anti-Aβ mAb Coverage With Evidence Development (CED) Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.