Recruiting

Observational Study

Sponsor:

Alzheimer's Disease and Related Disorders Association, Inc

Code:

NCT06170268

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Routine Care Documentation

Study Details

Brief 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.

Conditions

Alzheimer Disease

Study ID

NCT06170268

Start date

Oct 20, 2022

Status verified date

Nov, 2023

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Routine Care Documentation

Routine Care Documentation

Primary outcome measure

  • Evaluate whether FDA-approved treatments improve health outcomes (as measured by slowing of cognitive decline) over time in a real-world population in broad clinical settings. [ Time Frame: 2 years ]
  • Evaluate whether FDA-approved treatments improve health outcomes (as measured by slowing of cognitive decline) over time in a real-world population in broad clinical settings. [ Time Frame: 2 years ]
  • Evaluate whether FDA-approved treatments improve health outcomes (as measured by slowing of functional decline) over time in a real-world population in broad clinical settings. [ Time Frame: 2 years ]
  • Evaluate safety outcomes of FDA-approved treatments over time in a real-world population in broad clinical settings. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

ALZ-NET Operations Team

215-574-3181alz-net@acr.org

ALZ-NET Scientific Team

alzheimersnetwork@alz.org

Locations

Full List of Active Sites

Recruiting

Chicago, Illinois, United States, 60601

Contacts

Go to Site Finder https://www.alz-net.org/Find-a-Site

215-574-3181alz-net@acr.org

More Information

Sponsor

Alzheimer's Disease and Related Disorders Association, Inc

Last update posted

Dec 14, 2023

Last verified

Nov, 2023

Keywords

  • Alzheimer's Disease
  • Dementia
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Tauopathies
  • Neurodegenerative Diseases
  • Neurocognitive Disorders
  • Trials
  • Mild Cognitive Impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alzheimer's Disease and Related Disorders Association, Inc on 2023-12-14.