Protocol

The Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET)

The Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) collects longitudinal data from patients treated 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. 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. 

ALZ-NET Aims & Objectives

AIM 1: Establish the necessary network infrastructure:

• 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.
• 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:

• 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
• 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) or proxy has the ability to understand the purpose and risks of ALZ-NET and provide signed and dated informed consent.
2. Patient is at least 18 years of age at the time of informed consent
3. Patient has memory concerns and/or may have diagnosis of Alzheimer’s Disease and has been identified by an approved physician to be appropriate for treatment with novel FDA-approved therapies in real world clinical practice
4. Patient meets appropriate label designations for appropriate use of novel FDA-approved therapies.
5. Patient’s treating clinician has made the decision to treat the patient with novel FDA-approved therapy for Alzheimer’s Disease independent of the purpose of ALZ-NET and has already or will be initiating treatment.