Alzheimer's Network for Treatment and Diagnostics (ALZ-NET).
Jared Brosch, MD
Primary Investigator
Brief description of study
What is the purpose of this study?
ALZ-NET is a national, volunteer provider-enrolled longitudinal cohort registry with an expandable platform, allowing for the
collection of real-world data from enrolled patients being evaluated for or treated with novel FDA- approved AD therapies. ALZ-NET will be a resource for evidence gathering, information sharing and education across clinical and research communities, encouraging innovative, inclusive research and supporting opportunities to improve care.
ALZ-NET will align with the following objectives:
• Develop a multisite network for enrolling providers and collection of patient data.
• Collect baseline and longitudinal patient data, including measures of cognition, function, and
long-term safety.
• Collect and archive diagnostic, neuroimaging, genetic and fluid biomarkers.
• Track health outcomes and resource utilization through existing databases.
• Share de-identified data, images and biosamples with research community and other stakeholders.
Detailed description of study
What will happen during the study?
- ALZ-NET is designed to address key scientific and clinical questions on long term safety, clinical use and outcomes for patients being evaluated for or treated with novel FDA-approved. Treatments will be prescribed at the prescribing clinician’s discretion. Patients will be monitored by the treating clinician according to patient needs and local standard of care (SOC).
- ALZ-NET will collect data that characterizes patient demographics, diagnosis, medical conditions,
comorbidities, co-pathologies, concomitant medications, and cognitive and functional status at enrollment
and longitudinally at follow-up intervals. ALZ-NET will also capture data related to biomarker results
from imaging and biofluids (if applicable), safety outcomes, and healthcare resource utilization. This
protocol for retrospective and prospective human subjects research will be conducted according to and
International Conference on Harmonization Good Clinical Practice Guidelines, applicable government
regulations (e.g., Title 45, Part 46 Code of Federal Regulations), and the ACR research policies and
procedures. - To achieve sufficient data for ALZ-NET, patients will be monitored if they are evaluated for treatment,
throughout treatment duration, and following treatment completion for as long as they are willing.
Patients may stop using any novel FDA-approved therapy for AD, or any other commercially available
non-investigational AD therapy, during their ALZ-NET participation period. Patients who discontinue the
FDA-approved therapy for AD will continue to be followed for the duration of ALZ-NET with all clinical
evaluations, until one of the participation endpoints is met.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Alzheimer's Disease, Dementia, ADRD, Mild cognitive impairment, MCI
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Age: 18 years - 100 years
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Gender: All
Inclusion criteria:
1. Patient or patient’s legally authorized representative (LAR) (e.g., spouse or legal guardian) has
the ability to understand the purpose and risks of ALZ-NET and provide signed and dated
informed consent and authorization to use protected health information (PHI) in accordance
with national and local patient privacy regulations.
2. Patient is at least 18 years of age at the time of informed consent.
3. Patient has a diagnosis of MCI or dementia with clinical suspicion of Alzheimer’s disease (AD)
as contributing pathology and 1) is being evaluated for treatment or 2) will be initiating
treatment or 3) has already initiated treatment with novel FDA-approved AD therapies in real
world clinical practice.
4. If treatment is initiated at time of consent, patient meets appropriate label requirements and
treatment follows appropriate use recommendations for novel FDA-approved AD
therapy/therapies.
5. Patient’s treating clinician has made the decision to provide clinical care or treatment prior to
patient consent and independently of the purpose of ALZ-NET.
