Affiliated Studies

ALZ-NET is designed to work collaboratively with affiliated studies including those conducted by academia, industry, federal agencies, ALZ-NET project teams or others. The ALZ-NET infrastructure, data, and its network of providers can be used as a backbone for innovative research. There are a variety of ways to conduct an ALZ-NET-affiliated study, and the ALZ-NET team can work closely with collaborators from study conception and design to execution to meet the needs of each study from start to finish. ALZ-NET is able to collect quality data to support a variety of research needs, such as exploratory research as well as regulatory-required reporting using real-world data. Affiliated studies will be able to leverage the ALZ-NET data to inform additional analyses without increasing the burden on providers and patients for redundant data collection.

Affiliated study collaborations could include:

• Study preparations: feasibility, conceptualization, design and protocol feedback
• Project management: regularly scheduled communications and meetings
• IRB and informed consent alignment
• Data management: testing, maintenance, programming, transfers, and quality control
• Data analysis: reporting, aggregation, dashboarding
• Unique data element collection

Costs for ALZ-NET affiliated studies

Providing data, materials or other research and administrative services to affiliated studies involves costs that can vary widely. These costs are not covered by ALZ-NET. The cost to ALZ-NET to service affiliated studies needs to be paid for by the study investigator or organizational sponsor of an affiliated study. Costs will be considered on a case-by-case basis as each affiliated study will be designed in collaboration with each study investigator or organizational sponsor to answer different research questions.

Current affiliated studies

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease Following Appropriate Use Recommendations in a Medicare Population: a Coverage with Evidence Development (CED) Study

Status: Active
More Study Information
ClinicalTrials.gov ID: NCT06170268

ALZ-NET is approved by the Centers for Medicare and Medicaid Services (CMS) as a Coverage with Evidence Development (CED) study and can be used as a pathway to Medicare coverage for anti-amyloid Alzheimer’s therapies that have received traditional FDA approval. The principal purpose of the study is to investigate the long-term effectiveness and safety of new treatments and whether these treatments improve patient health outcomes. This is the first of ALZ-NET’s affiliated studies that utilizes the infrastructure of the national ALZ-NET provider-enrolled patient registry protocol to conduct specific and detailed analysis on ALZ-NET data.

LEQEMBI® (lecanemab-irmb) Postmarketing Requirement Study

Status: Planning in Progress
ClinicalTrials.gov ID: Pending

As with all therapies in this class and as a postmarketing requirement of FDA approval, Eisai Inc. is required to conduct a registry-based, prospective, observational study to evaluate clinical safety outcomes among Alzheimer’s disease patients who are being treated with lecanemab-irmb using, for example, the Alzheimer’s Network for Treatment and Diagnostics (ALZ-NET) registry. ALZ-NET is collaborating with Eisai Inc. on an ALZ-NET-affiliated study that will collect data to support the postmarketing requirement study. This is an example of an ALZ-NET affiliated study that utilizes the infrastructure of the national ALZ-NET provider-enrolled patient registry to conduct regulatory-grade data collection and sharing to support regulatory reporting requirements.