Alzheimer's National Registry for Treatment and Diagnostics(ALZ-NET)
Purpose
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.
Condition
- Alzheimer Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Case-Only
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Not Applicable/Open Label Registry | 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. |
|
Recruiting Locations
Chicago, Illinois 60601
More Details
- NCT ID
- NCT06170268
- Status
- Recruiting
- Sponsor
- Alzheimer's Disease and Related Disorders Association, Inc
Detailed Description
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.