Coverage with evidence development for anti-Aβ mAb treatment in Alzheimer's patients
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)
This study is testing how well a new Alzheimer's treatment works and its safety by tracking the progress of people with mild Alzheimer's or mild cognitive impairment over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8680 (estimated) |
| Sex | All |
| Sponsor | Centers for Medicare and Medicaid Services/ Coverage and Analysis Group Federal |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06058234 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, longitudinal observational study that collects clinical data, patient assessments, and administrative claims data from Medicare beneficiaries diagnosed with mild Alzheimer's disease or mild cognitive impairment due to Alzheimer's disease. Clinicians will evaluate patients to confirm eligibility based on neurocognitive assessments and biomarker testing for amyloid presence. Data on cognition, function, and treatment-related outcomes will be submitted to a registry every six months for up to 24 months, allowing for comprehensive monitoring of treatment effects and safety. The study aims to align with the National Coverage Determination for monoclonal antibodies targeting amyloid in Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates for this study are Medicare patients with a clinical diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia, confirmed by amyloid pathology.
Not a fit: Patients who do not have a clinical diagnosis of mild cognitive impairment or mild Alzheimer's dementia, or those without confirmed amyloid pathology, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of anti-Aβ mAb treatments for patients with mild Alzheimer's disease and mild cognitive impairment.
How similar studies have performed: Other studies investigating monoclonal antibodies targeting amyloid have shown promise, but this specific approach of coverage with evidence development is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Centers for Medicare and Medicaid Services — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Cms Cag
- Email: CMS_caginquiries@cms.hhs.gov
- Phone: 410-786-2281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.