Alzheimer DiseaseALZ-NETNCT06170268
Alzheimer's National Registry for Treatment and Diagnostics(ALZ-NET)
An observational study of Alzheimer Disease, run by Alzheimer's Disease and Related Disorders Association, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Routine Care Documentation
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2022to Dec 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ALZ-NET Scientific Team contact
United States1 site, 1 recruiting
- Recruiting
Full List of Active Sites
Chicago, Illinois, 60601
Go to Site Finder https://www.alz-net.org/Find-a-Site, 215-574-3181 ext. 4181, alz-net@acr.org
About this study
Official title: Alzheimer's National Registry for Treatment and Diagnostics
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.
Read the detailed description
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 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 aims to assess the clinical course of people from a variety of backgrounds and communities, to achieve representativeness beyond the populations historically enrolled in clinical trials. ALZ-NET will be a resource for evidence gathering, information sharing, and education across clinical and research communities, encouraging innovative, inclusive research and supporting opportunities to improve clinical care delivery.
ALZ-NET will align with the following objectives:
- Collect baseline and longitudinal patient data, including measures of cognition, function, and long-term safety.
- Collect and archive diagnostic, neuroimaging, genetic and fluid biomarkers.
- Track health outcomes and resource utilization through existing databases.
- Share deidentified data, images and biosamples with the research community and other stakeholders.
All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines. ALZ-NET will collect longitudinal data through site submitted case report forms and payer claims. Additional objectives of ALZ-NET are to establish a biorepository of plasma, CSF and DNA samples and to archive brain images from participants who consent to these optional elements.
In addition to the aims and objectives outlined within this protocol, ALZ-NET will serve as a backbone registry and platform for collection of regulatory grade data and collaboration with affiliated studies. Affiliated studies are thoroughly reviewed by the ALZ-NET Steering Committee before receiving affiliation approval. ALZ-NET will allow for seamless co enrollment of participants that are being evaluated for or receiving a novel FDA-approved treatment for AD. This collaboration structure is designed to reduce the operational burden of participating sites and patients.
- Conditions
- Alzheimer Disease
- Being tested
- Routine Care Documentation
- Keywords
- Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Trials, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Care DocumentationOther
Routine Care Documentation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine Care Documentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start20 Oct 2022
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Alzheimer's Disease and Related Disorders Association, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Radiology, The Critical Path Institute, Brown University, American Society of Neuroradiology
- Responsible party
- Sponsor
- Investigators
- Gil Rabinovici, MD, Principal investigator, University of California, San FranciscoMaria C Carillo, PhD, Principal investigator, Alzheimer's AssociationMichael S Rafii, MD, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170268
- Sponsor's protocol ID
- ALZ-NET
- Acronym
- ALZ-NET
- Status last verified
- Nov 2023
- First submitted
- 7 Jul 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
2022 Alzheimer's disease facts and figures. Alzheimers Dement. 2022 Apr;18(4):700-789. doi: 10.1002/alz.12638. Epub 2022 Mar 14.
PubMed 35289055Rajan 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.
PubMed 34043283Guerreiro R, Bras J. The age factor in Alzheimer's disease. Genome Med. 2015 Oct 20;7:106. doi: 10.1186/s13073-015-0232-5.
PubMed 26482651McKhann 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.
PubMed 21514250Albert 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.
PubMed 21514249Sperling 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.
PubMed 215142482021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23.
PubMed 33756057
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alzheimer's National Registry for Treatment and Diagnostics
- ClinicalTrials.gov ID
- NCT06170268
- Acronym / sponsor ID
- ALZ-NET / ALZ-NET
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Alzheimer's Disease and Related Disorders Association, IncUniversity, hospital or other
- Collaborators
- American College of Radiology, The Critical Path Institute, Brown University, American Society of Neuroradiology
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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 aims to assess the clinical course of people from a variety of backgrounds and communities, to achieve representativeness beyond the populations historically enrolled in clinical trials. ALZ-NET will be a resource for evidence gathering, information sharing, and education across clinical and research communities, encouraging innovative, inclusive research and supporting opportunities to improve clinical care delivery.
ALZ-NET will align with the following objectives:
- Collect baseline and longitudinal patient data, including measures of cognition, function, and long-term safety.
- Collect and archive diagnostic, neuroimaging, genetic and fluid biomarkers.
- Track health outcomes and resource utilization through existing databases.
- Share deidentified data, images and biosamples with the research community and other stakeholders.
All participating physicians and site staff will complete comprehensive training to ensure adherence of data requirements and registry timelines. ALZ-NET will collect longitudinal data through site submitted case report forms and payer claims. Additional objectives of ALZ-NET are to establish a biorepository of plasma, CSF and DNA samples and to archive brain images from participants who consent to these optional elements.
In addition to the aims and objectives outlined within this protocol, ALZ-NET will serve as a backbone registry and platform for collection of regulatory grade data and collaboration with affiliated studies. Affiliated studies are thoroughly reviewed by the ALZ-NET Steering Committee before receiving affiliation approval. ALZ-NET will allow for seamless co enrollment of participants that are being evaluated for or receiving a novel FDA-approved treatment for AD. This collaboration structure is designed to reduce the operational burden of participating sites and patients.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not Applicable/Open Label Registry | – | Other: Routine Care DocumentationALZ-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Care DocumentationRoutine Care Documentation | Other | Not Applicable/Open Label Registry |
Primary outcome
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 352890552022 Alzheimer's disease facts and figures. Alzheimers Dement. 2022 Apr;18(4):700-789. doi: 10.1002/alz.12638. Epub 2022 Mar 14.
- Background: PubMed 34043283Rajan 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.
- Background: PubMed 26482651Guerreiro R, Bras J. The age factor in Alzheimer's disease. Genome Med. 2015 Oct 20;7:106. doi: 10.1186/s13073-015-0232-5.
- Background: PubMed 21514250McKhann 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.
- Background: PubMed 21514249Albert 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.
- Background: PubMed 21514248Sperling 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.
- Background: PubMed 337560572021 Alzheimer's disease facts and figures. Alzheimers Dement. 2021 Mar;17(3):327-406. doi: 10.1002/alz.12328. Epub 2021 Mar 23.
- ALZ-NET WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ALZ-NET Scientific Team contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Alzheimer's Disease and Related Disorders Association, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALZ-NET Operations Team (215-574-3181 ext. 4181, alz-net@acr.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06170268, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.