NCT06170268

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Oct 2022Dec 2032

First Submitted

Initial submission to the registry

July 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

December 14, 2023

Status Verified

November 1, 2023

Enrollment Period

10.1 years

First QC Date

July 7, 2022

Last Update Submit

December 5, 2023

Conditions

Alzheimer Disease

Keywords

Alzheimer's DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersTrialsMild Cognitive Impairment

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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.

    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.

    2 years

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

    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)

    2 years

Study Arms (1)

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.

Other: Routine Care Documentation

Interventions

Routine Care DocumentationOTHER

Routine Care Documentation

Not Applicable/Open Label Registry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults of all racial and ethnic backrounds that have memory concerns and/ or may have diagnosis of Alzheimer's disease (AD) and has been identified by an approved site investigator (as defined by protocol) to be appropriate for treatment with novel FDA-approved therapies in real world clinical practice.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Full List of Active Sites

Chicago, Illinois, 60601, United States

RECRUITING

Related Publications (7)

  • 2022 Alzheimer's disease facts and figures. Alzheimers Dement. 2022 Apr;18(4):700-789. doi: 10.1002/alz.12638. Epub 2022 Mar 14.

    PMID: 35289055BACKGROUND

  • Rajan KB, Weuve J, Barnes LL, McAninch EA, Wilson RS, Evans DA. Population estimate of people with clinical Alzheimer's disease and mild cognitive impairment in the United States (2020-2060). Alzheimers Dement. 2021 Dec;17(12):1966-1975. doi: 10.1002/alz.12362. Epub 2021 May 27.

    PMID: 34043283BACKGROUND

  • Guerreiro R, Bras J. The age factor in Alzheimer's disease. Genome Med. 2015 Oct 20;7:106. doi: 10.1186/s13073-015-0232-5.

    PMID: 26482651BACKGROUND

  • McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.

    PMID: 21514250BACKGROUND

  • Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.

    PMID: 21514249BACKGROUND

  • Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR Jr, Kaye J, Montine TJ, Park DC, Reiman EM, Rowe CC, Siemers E, Stern Y, Yaffe K, Carrillo MC, Thies B, Morrison-Bogorad M, Wagster MV, Phelps CH. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):280-92. doi: 10.1016/j.jalz.2011.03.003. Epub 2011 Apr 21.

    PMID: 21514248BACKGROUND

  • 2021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23.

    PMID: 33756057BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen collection and retention will be included in a future protocol amendment. Detail will be provided once available and approved by the IRB of record.

MeSH Terms

Conditions

Alzheimer DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Mental DisordersCognition Disorders

Study Officials

  • Gil Rabinovici, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Maria C Carillo, PhD

    Alzheimer's Association

    PRINCIPAL INVESTIGATOR

  • Michael S Rafii, MD, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ALZ-NET Operations Team

CONTACT

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

ALZ-NET Scientific Team

CONTACT

alzheimersnetwork@alz.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

December 14, 2023

Study Start

October 20, 2022

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

December 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

ALZ-NET is committed to providing investigators in academia and industry an opportunity to access data collected as part of the network for purposes that are consistent with the goals of ALZ-NET. ALZ-NET archives the clinical and image data obtained as part of its research activity. This archive can be used for secondary research studies, to guide further drug or technology development, and for educational purposes. Access to CMS claims data used in ALZ-NET is handled separately and requires permission from CMS. Any individual or entity may submit a request for the clinical data, image data, or images linked to clinical data archived by ALZ-NET. The Network will provide requesters the raw data as it is archived in the database. However, requesters can specify subsets of data they desire using the annotated elements from the case report forms. The identity (and identifiable information) of network participants, sites and investigators will not be provided to requesters.

Access Criteria
The application forms for requesting archived clinical and image data is available on upon request. Requests for access to the ALZ-NET archive should be sent to alz-net@acr.org. Before indicating in a grant proposal that clinical and/or image data archived by ALZ-NET will be used to conduct the proposed research, an investigator should submit a request and obtain written approval from ALZ-NET prior to submitting the grant proposal. ALZNET treats such requests as it does any other.

Locations

US(1)