Alzheimer's National Registry for Treatment and Diagnostics

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Full List of Active Sites
RECRUITING
Chicago
Contact Information
Primary
ALZ-NET Operations Team
alz-net@acr.org
215-574-3181
Backup
ALZ-NET Scientific Team
alzheimersnetwork@alz.org
Time Frame
Start Date: 2022-10-20
Estimated Completion Date: 2032-12
Participants
Target number of participants: 20000
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Brown University, American Society of Neuroradiology, The Critical Path Institute, American College of Radiology
Leads: Alzheimer's Disease and Related Disorders Association, Inc

This content was sourced from clinicaltrials.gov