Routine Care Documentation for Alzheimer's Disease
(ALZ-NET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tracks the real-life effectiveness of new Alzheimer's treatments. Researchers aim to gather data on the safety and long-term effects of FDA-approved therapies for Alzheimer's disease (AD). Patients with mild cognitive impairment (MCI) or dementia suspected to be related to Alzheimer's, who are starting or already on these new treatments, can participate. This trial offers a chance to contribute to better understanding and care for Alzheimer's in real-world settings. Participants will help researchers observe how these treatments perform outside the lab. As a Phase 4 trial, the study focuses on understanding how FDA-approved treatments benefit more patients in everyday environments.
Do I need to stop my current medications for this Alzheimer's trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to understand how your current treatments might interact with the trial.
What is the safety track record for the treatments in this trial?
Research shows that the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) focuses on monitoring the safety of new Alzheimer's treatments. These treatments have already received FDA approval, indicating prior safety testing in other studies.
One study found no new safety concerns when patients were monitored over time. Additionally, a long-term follow-up showed only a slow increase in amyloid (a protein linked to Alzheimer's) without any new safety issues. This information reassures that these treatments are well-tolerated by patients.
ALZ-NET aims to continuously collect real-world safety data from patients using these treatments. This ongoing research helps doctors understand how the treatments work in everyday life. Overall, the evidence so far supports the safety of these Alzheimer’s treatments in humans.12345Why are researchers excited about this trial?
Researchers are excited about the ALZ-NET protocol because it offers a fresh way to gather real-world data on Alzheimer's treatments. Unlike traditional studies that focus on a specific drug, ALZ-NET is treatment agnostic, meaning it collects data from patients on various FDA-approved therapies. This approach allows for a comprehensive understanding of how different treatments perform in everyday settings, guided by FDA labels and clinician expertise. By expanding our knowledge of real-world effectiveness, ALZ-NET aims to refine treatment strategies and improve patient outcomes in Alzheimer's care.
What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?
Research has shown that new FDA-approved treatments for Alzheimer's disease are promising in managing symptoms and improving quality of life. ALZ-NET, part of this trial, collects data on the effectiveness of these treatments in real-life situations. This includes observing their impact on memory and daily activities over time. Some patients have experienced improved thinking abilities and a slower progression of symptoms. ALZ-NET aims to gather detailed information on the performance of these treatments in everyday life, providing valuable insights into their long-term benefits and safety.12367
Who Is on the Research Team?
Gil Rabinovici, MD
Principal Investigator
University of California, San Francisco
Maria C Carillo, PhD
Principal Investigator
Alzheimer's Association
Michael S Rafii, MD, PhD
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Data Collection
Collection of baseline patient data, including measures of cognition, function, and safety
Longitudinal Data Collection
Ongoing collection of clinical and safety data for patients treated with novel FDA-approved Alzheimer's therapies
Follow-up
Participants are monitored for long-term health outcomes and safety after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ALZ-NET
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alzheimer's Disease and Related Disorders Association, Inc
Lead Sponsor
Brown University
Collaborator
The Critical Path Institute
Collaborator
American Society of Neuroradiology
Collaborator
American College of Radiology
Collaborator
Citations
ALZ-NET: Alzheimer's Network for Treatment and Diagnostics
ALZ-NET collects clinical and safety data about patients being evaluated for memory concerns or receiving new FDA-approved treatments for Alzheimer's disease, ...
About ALZ-NET
Learn how ALZ-NET works and about its cohesive approach to Alzheimer's detection, diagnosis, treatment and care that benefits all communities.
Alzheimer's Association launches ALZ‐NET: A long‐term ...
What will ALZ‐NET gather, and what will it produce? “ALZ‐NET will gather data on treatment effectiveness and side effects in real‐world clinical practice ...
NCT06170268 | Alzheimer's National Registry for ...
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 ...
Generating real‐world evidence in Alzheimer's disease ...
Registries, such as the ALZ-NET registry, are data collection systems that capture a wide range of long-term outcome data. In contrast, both ...
Research News and Highlights | ALZ-NET
Long-term follow-up showed slow re-accumulation of amyloid of about 2.5 centiloids per year, and no new safety concerns were observed. These findings underscore ...
ALZ-NET and Eisai Inc. to Collect Real-World Data ...
Eisai Inc. will evaluate lecanemab clinical safety outcomes among early Alzheimer's patients and collaborate on an ALZ-NET-affiliated study.
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