Alzheimer's National Registry for Treatment and Diagnostics (ALZ-NET)

This study, called ALZ-NET, is an observational registry for people with Alzheimer's disease. It aims to collect information on how well FDA-approved treatments work in real-world settings. Researchers will track whether these treatments slow down memory and thinking decline (cognitive decline) and daily function decline over two years. You might be able to join if you are 18 or older, and you or your legal representative can understand the study and provide consent. This registry helps researchers learn more about how different treatments affect a wide range of people with Alzheimer's.

Study design
This is an observational study, meaning researchers will collect information without giving specific treatments. It plans to include up to 20,000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will evaluate health outcomes over two years.

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NCT06170268

Alzheimer's National Registry for Treatment and Diagnostics(ALZ-NET)

Recruiting
Not specifiedAges 18+Observational
Alzheimer's Disease and Related Disorders Association, Inc
~20,000 participants
Updated 2023-12-14 on ClinicalTrials.gov
What's tested:Routine Care Documentation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 2 years
+3 more outcomes measured
Alzheimer Disease
1 sites across 1 states
Illinois1
  • 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

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Eligibility criteria

Inclusion

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.
  • 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.2 years

    The primary measure of cognitive status will be the overall score of Montreal Cognitive Assessment (MoCA). MoCA is measured on a scale of 0 to 30 with higher scores indicating better cognitive function.

  • 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.2 years

    The primary measures of cognitive status will be the overall score of the Mini Mental State Examination (MMSE). MMSE is measured on a scale of 0 to 30 with higher scores indicating better cognitive function.

  • 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.2 years

    The primary measure of functional status will be the overall score of the Functional Activities Questionnaire (FAQ). FAQ is measured on a scale of 0 to 30 with higher scores indicating more impaired function.

  • Evaluate safety outcomes of FDA-approved treatments over time in a real-world population in broad clinical settings.2 years

    The measures of safety will be summaries of rates of adverse events over time. Specific safety outcomes of interest include amyloid related imaging abnormalities (ARIA)