Alzheimer's National Registry for Treatment and Diagnostics(ALZ-NET)

Study Overview
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Brief Summary
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The Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) will collect longitudinal clinical and safety data for enrolled patients being evaluated for or treated with novel FDA-approved Alzheimer's disease (AD) therapies. ALZ-NET is a longitudinal registry with an expandable platform, designed to grow with scientific and medical advancements. As new treatments are approved and implemented in care, ALZ-NET will track the long-term health outcomes associated with their use in a real-world setting. ALZ-NET is a resource for evidence gathering, information sharing and education across clinical and research communities, encouraging innovative research and supporting opportunities to improve clinical care delivery. All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines.

Detailed Description
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ALZ-NET is collecting longitudinal clinical and safety data for enrolled patients that are being evaluated for or being treated with novel FDA-approved AD therapies. ALZ-NET is a longitudinal registry with an expandable platform, designed to grow with scientific and medical advancements. As new treatments are approved and implemented in care, ALZ-NET will track the long-term health outcomes associated with their use in a real-world setting. ALZ-NET aims to assess the clinical course of people from a variety of backgrounds and communities, to achieve representativeness beyond the populations historically enrolled in clinical trials. 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 clinical care delivery. ALZ-NET will align with the following objectives: 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 deidentified data, images and biosamples with the research community and other stakeholders. All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines. ALZ-NET will collect longitudinal data through site submitted case report forms and payer claims. Additional objectives of ALZ-NET are to establish a biorepository of plasma, CSF and DNA samples and to archive brain images from participants who consent to these optional elements. In addition to the aims and objectives outlined within this protocol, ALZ-NET will serve as a backbone registry and platform for collection of regulatory grade data and collaboration with affiliated studies. Affiliated studies are thoroughly reviewed by the ALZ-NET Steering Committee before receiving affiliation approval. ALZ-NET will allow for seamless co enrollment of participants that are being evaluated for or receiving a novel FDA-approved treatment for AD. This collaboration structure is designed to reduce the operational burden of participating sites and patients.

Official Title
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Alzheimer's National Registry for Treatment and Diagnostics

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Routine Care Documentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient or patient's legally authorized representative (LAR) or proxy (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. Patient is at least 18 years of age at the time of informed consent. Patient has a diagnosis of MCI or dementia with clinical suspicion of 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. If treatment is initiated at the time of consent, patient meets appropriate label requirements and treatment follows appropriate use recommendations for novel FDA-approved AD therapy/therapies. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Not Applicable/Open Label Registry<br>ALZ-NET is a growing network of sites that follow participants over time with an expandable platform, allowing for the collection of real-world data from enrolled patients being evaluated for or receiving any novel FDA-approved Alzheimer's disease therapies. ALZ-NET is treatment agnostic. Drug treatment dosage, frequency and duration will be guided by FDA label and clinician judgment as part of treatment and patient management. | Other: Routine Care Documentation<br>* Routine Care Documentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate whether FDA-approved treatments improve health outcomes (as measured by slowing of cognitive decline) over time in a real-world population in broad clinical settings. | The primary measure of cognitive status will be the overall score of Montreal Cognitive Assessment (MoCA). MoCA is measured on a scale of 0 to 30 with higher scores indicating better cognitive function. | 2 years | 
| Evaluate whether FDA-approved treatments improve health outcomes (as measured by slowing of cognitive decline) over time in a real-world population in broad clinical settings. | The primary measures of cognitive status will be the overall score of the Mini Mental State Examination (MMSE). MMSE is measured on a scale of 0 to 30 with higher scores indicating better cognitive function. | 2 years | 
| Evaluate whether FDA-approved treatments improve health outcomes (as measured by slowing of functional decline) over time in a real-world population in broad clinical settings. | The primary measure of functional status will be the overall score of the Functional Activities Questionnaire (FAQ). FAQ is measured on a scale of 0 to 30 with higher scores indicating more impaired function. | 2 years | 
| Evaluate safety outcomes of FDA-approved treatments over time in a real-world population in broad clinical settings. | The measures of safety will be summaries of rates of adverse events over time. Specific safety outcomes of interest include amyloid related imaging abnormalities (ARIA) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Trials, Mild Cognitive Impairment