Protocol

ALZ-NET Purpose

The Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) collects longitudinal data from patients being evaluated for or treating with novel FDA-approved therapies for Alzheimer’s disease (AD), and tracks patient health outcomes (clinical response and safety), associated with use in real-world settings.   

Protocol Training ModuleProtocol Synopsis Protocol Acknowledgement

• Novel FDA-approved therapies for AD are drugs that have received approval as treatments for AD from the U.S. Food and Drug Administration since 2021. 
• ALZ-NET aims to assess the clinical course of individuals from a variety of backgrounds and communities, to achieve representativeness beyond the populations historically enrolled in clinical trials.
• ALZ-NET is a resource for evidence gathering, information sharing, and education across clinical and research communities, encouraging innovative, inclusive research, and supporting opportunities to improve care. 

Coverage with Evidence Development

ALZ-NET is approved by the Centers for Medicare and Medicaid Services (CMS) as a Coverage with Evidence Development (CED) study.

• ALZ-NET can be used as a pathway to Medicare coverage for anti-amyloid Alzheimer's therapies that have received traditional (full) FDA approval.
• This currently includes Leqembi (lecanemab), an anti-amyloid Alzheimer's disease treatment that has traditional FDA approval.

ALZ-NET Aims & Objectives

AIM 1: Establish the necessary network infrastructure to develop a database to gather regulatory grade, longitudinal data from patients being treated with novel FDA-approved therapies for AD in real-world clinical practice, establish an image repository to collect and archive diagnostic and safety neuroimaging studies and establish a biorepository for specimens and systems to distribute specimens as research projects are approved.

AIM 2: The registry will develop mechanisms to co-enroll participants in affiliated trials

AIM 3: The registry will collect data to evaluate long term safety, clinical use and outcomes to characterize the patient population and clinician prescribing patterns, track baseline and longitudinal safety, cognitive, and functional trajectories, assess patient management including initiation and duration of treatment and evaluate longitudinal safety and tolerability

AIM 4: Merge and compare ALZ-NET data with existing databases to further understand patient outcomes and resource utilization

AIM 5: Establish and implement infrastructure for sharing of de-identified data, images and biosamples.

Patient Eligibility 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.