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Alzheimer's Disease(AD)InRADNCT07213700

InRAD Observational Study

An observational study of Alzheimer's Disease(AD) and Mild Cognitive Impairment (MCI), run by Stichting International Registry for Alzheimer's Disease and other Dementias Foundation at 23 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this international observational study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across global clinical centers. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
None, this is a non-interventional observational study
How many people
50,000 participants
Where
23 sitesin 17 countries
Study dates
30 Mar 2026to Jan 2036
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: Participants will be from centers part of the InRAD international network

Who may be able to join

  • Be undergoing diagnostic work-up for Alzheimer's disease (AD), OR
  • Have a confirmed diagnosis of AD (whether currently treated with an AD-specific treatment, or untreated),
  • Be attending an InRAD Center,
  • Have provided informed consent for long-term follow-up

Who cannot join

  • -Any patient or legal representative who is unable or unwilling to provide a signed informed consent form
  • The protocol does not specify a lower or upper age limit. Participants are expected to be predominantly adults, and can include younger adults with early-onset or genetically determined Alzheimer's disease (e.g. Down syndrome-associated Alzheimer's disease).

Trial locations and contacts

23 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Scientific Officer contact

office@inradnetwork.org

23 sites in 17 countries

Romania3 sites, 3 recruiting

  • County Emergency Clinic Hospital Brasov/Spitalul Clinic Judetean de Urgenta Brasov

    Brasov, 500326

    Cristian Falup-Pecurariu

    Recruiting

  • Saint Luke Hospital for Chronic Disease-Geriatrics and Gerontology II

    Bucharest, 041915

    Luiza Spiru

    Recruiting

  • Fundatia Ana Aslan International

    Bucharest

    Luiza Spiru

    Recruiting

Other trials in Romania

Austria2 sites, 2 recruiting

  • Medical University of Graz

    Graz, 8010

    Stephan Seiler

    Recruiting

  • Kardinal Schwarzenberg Klinikum

    Schwarzach, 5620

    Fabian Zach

    Recruiting

Other trials in Austria

Greece2 sites, 2 recruiting

  • Aiginition Hospital

    Athens, 115 28

    Nikolaos Scarmeas

    Recruiting

  • Panhellenic Federation of Alzheimer's Disease and Related Disorders

    Thessaloniki

    Magda Tsolaki

    Recruiting

Other trials in Greece

Italy2 sites, 2 recruiting

  • B.R.A.N.D. Center - Neurologia Universitaria - Policinico Foggia

    Foggia

    Emanuele D'Amico

    Recruiting

  • Ospedale San Raffaele

    Milan, 20132

    Federica Agosta

    Recruiting

Other trials in Italy

Netherlands2 sites, 2 recruiting

  • Stichting Amsterdam UMC (location VUmc) - ABOARD Cohort

    Amsterdam

    Casper De Boer

    Recruiting

  • Stichting Amsterdam UMC (location VUmc) - Amsterdam Dementia Cohort

    Amsterdam

    Jort Vijverberg

    Recruiting

Other trials in Netherlands

Australia1 site, 1 recruiting

  • Alfred Hospital

    Melbourne, 3004

    David Darby

    Recruiting

Other trials in Australia

Belgium1 site, 1 recruiting

  • UZLeuven

    Leuven, 3000

    Rik Vandenberghe

    Recruiting

Other trials in Belgium

Brazil1 site, 1 recruiting

  • Irmandade da Santa Casa de São Paulo

    São Paulo, 01221-010

    Diogo Haddad Santos

    Recruiting

Other trials in Brazil

Czechia1 site, 1 recruiting

  • Motol and Homolka University Hospital (UHM)

    Prague, 150 06

    Jakub Hort

    Recruiting

Other trials in Czechia

Egypt1 site, 1 recruiting

  • Ain Shams University

    Cairo

    Samia Ahmed Abdul-Rahman

    Recruiting

Other trials in Egypt

Ireland1 site, 1 recruiting

  • The Adelaide and Meath Hospital

    Dublin

    Antoinette O'Connor

    Recruiting

Other trials in Ireland

Poland1 site, 1 recruiting

  • NeuroProtect

    Warsaw, 01-684

    Maciej Czarnecki

    Recruiting

Other trials in Poland

Portugal1 site, 1 recruiting

  • Hospital de Santo António

    Porto, 4050-011

    Inês Laranjinha

    Recruiting

Other trials in Portugal

Saudi Arabia1 site, 1 recruiting

  • King Faisal Specialist Hospital

    Riyadh, 11564

    Yara AlKhodair

    Recruiting

Other trials in Saudi Arabia

Spain1 site, 1 recruiting

  • Fundació ACE, Institut Català de Neurociències Aplicades

    Barcelona, 08028

    Mercè Boada

    Recruiting

Other trials in Spain

Taiwan1 site, 1 recruiting

  • New Taipei Municipal TuCheng Hospital

    New Taipei City, 236

    Jung-Lung Hsu

    Not yet recruiting

Other trials in Taiwan

Turkey (Türkiye)1 site, 1 recruiting

  • Istanbul University Çapa Hospital

    Istanbul, 34093

    Başar Bilgiç

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The International Registry for Alzheimer's Disease and Other Dementias (InRAD): An International Registry Observational Study Dedicated to Evaluating Outcomes Data in Alzheimer's Disease

The goal of this international observational study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across global clinical centers.

The InRAD Registry Observational Study has several aims:

Read more
  • To collect medical information for many years from a large group of people with Alzheimer's disease. This will be used for research, which will support improved understanding about the disease.
  • To enable researchers to look at the effectiveness, usefulness and safety of treatments for Alzheimer's disease.
  • To enable researchers to answer similar research questions and compare results in many different areas of the world.

People with Alzheimer's disease who meet the eligibility criteria and agree to participate in the Study will be asked to visit their doctor (e.g. psychiatrist, geriatrician, or neurologist) at least once a year, or as frequently as is needed for their care. During or after their appointments they may be offered assessments, tests, medications, and treatments as determined by their doctor and their team. This is an observational data collection.

Read the detailed description

The study protocol is owned by all InRAD Observational Study Investigators. All centers taking part in InRAD are the data controllers. InRAD is a data processor and is providing operational management and system support.

Study Type: Prospective, non-interventional, multinational observational cohort study.

Study Objective: The primary goal of the InRAD Observational Study is to collect and analyze real-world data (RWD) to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD). The study aims to:

  • Assess disease stage transitions, cognitive and functional changes over time.
  • Examine the relationship between demographics, comorbidities, diagnostic and monitoring tests, drug exposures, and outcomes.
  • Compare disease demographics and outcomes across countries and regions.
  • Characterize the occurrence of medical events, including Serious Adverse Events (SAEs) and Adverse Events (AEs), particularly in relation to AD-specific treatments.

Study Population: Adults undergoing diagnostic work-up for Alzheimer's disease or already diagnosed. Includes treated, treatment-eligible, and untreated patients. Participants must be attending an InRAD Center and provide informed consent for long-term follow-up.

Recruitment and Consent: Recruitment is open to global clinical centers with qualified investigators. Informed consent is obtained from patients and, where applicable, their caregivers. Consent includes authorization to share pseudonymized demographic and medical data with the InRAD Registry.

Data Collection: Investigators use the InRAD Web cloud-based data-entry platform and agree to collect the defined Minimum Dataset at least annually for their patients:

Minimum Dataset (MDS):

  • Patient demographics
  • Disease characteristics
  • Clinical outcomes
  • Safety data
  • Treatment details

In addition to the Minimum Dataset, Investigators may collect a variety of disease-specific or other data-fields of interest from the Extended Dataset:

Extended Dataset (EDS):

  • Lifestyle factors
  • Biomarkers and imaging data
  • Care partner information
  • Quality of life and burden assessments

Centers, through their PIs, and the InRAD SLG (Scientific Leadership Group), may propose research analyses and cohort sub-studies of interest to be conducted using the pooled Registry dataset or subsets of the Registry data.

For each analysis and sub-study proposal, the Center, through its PI, always exclusively decide whether to participate and contribute their Center data for use in the research.

The IT tool is owned, maintained and freely provided by the InRAD Foundation to Member Centers to enable and support the Study.

Pseudonymized data is to be submitted to the InRAD registry at least biannually and may be updated more frequently depending on clinical practice.

Governance and Oversight: The study is coordinated by the InRAD Foundation and governed by its Scientific Leadership Group (SLG). Each participating center is responsible for obtaining Ethics Committee (EC) or Institutional Review Board (IRB) approval unless exempt. No Data Monitoring Committee (DMC) is appointed, consistent with the non-interventional nature of the study.

Safety Monitoring: SAEs and other medical events are recorded using MedDRA coding. Centers are responsible for reporting SAEs to local authorities and manufacturers. The registry supports longitudinal safety analyses to identify treatment-related risks.

Participant Reimbursement: No financial reimbursement is provided. Diagnostic and treatment costs are covered by patients, their healthcare provider or their health insurance.

Sampling: The study does not use randomization or stratified sampling. Instead, it includes all eligible and consenting patients encountered during routine care at participating centers, reflecting a real-world clinical population.

Funding: InRAD is coordinated by the independent International Registry for Alzheimer's Disease and Other Dementias Foundation, a health-related not-for-profit entity incorporated in the Netherlands.

InRAD has received financial contributions from the pharmaceutical industry. InRAD does not endorse any companies or products. InRAD is operated independently from these companies.

Being tested
None, this is a non-interventional observational study
Keywords
Alzheimer's disease (AD), Dementia, Observational study, Real-world data (RWD), International registry, Cognitive decline, InRAD Registry, InRAD Foundation, Cognitive screening (MoCA, MMSE), AD-specific therapies, Clinical staging
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None, this is a non-interventional observational studyOther

    None applicable

Study groups in NCT07213700
Study groupRoleWhat they receive
Alzheimer's Disease Registry ParticipantsIndividuals diagnosed with Alzheimer's disease or undergoing diagnostic work-up, enrolled in the InRAD Registry for long-term observational follow-up. This cohort includes treated, treatment-eligible, and untreated patients across global clinical centers participating in routine care and data collection.
Receives: Other: None, this is a non-interventional observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transitions in Alzheimer's Disease Clinical Stage Over Time

    Longitudinal trajectory of disease stage, assessed by the treating clinician in routine clinical practice using the NIA-AA 2018/2024 clinical staging criteria for individuals on the Alzheimer's disease continuum (Stage 0 to Stage 6, with higher stages indicating more advanced disease):

    • Stage 0, asymptomatic, deterministic gene;
    • Stage 1, asymptomatic, biomarker evidence only;
    • Stage 2, transitional decline (mild detectable change, minimal impact on daily function);
    • Stage 3, cognitive impairment with early functional impact;
    • Stage 4, dementia with mild functional impairment;
    • Stage 5, dementia with moderate functional impairment;
    • Stage 6, dementia with severe functional impairment.

    As part of the InRAD Minimum Dataset, clinical stage is entered at study entry and at least once a year thereafter, with additional entries possible at further clinical visits, to characterize the frequency, direction and timing of transitions between disease stages over time.

    Measured: At study entry and at least annually thereafter, until death, withdrawal of consent or end of clinical follow-up (10 years)

  2. Change in Cognition Over Time

    Longitudinal trajectory of global cognitive function, assessed in routine clinical practice using a cognitive screening test: either the Montreal Cognitive Assessment (MoCA) or the Mini-Mental State Examination (MMSE). Both have a total score range of 0 to 30, with higher scores indicating better cognitive function. As part of the InRAD Minimum Dataset, test date, version and total score are entered at study entry and at least once a year thereafter, with additional entries possible at further clinical visits, to characterize the rate and pattern of cognitive change over time.

    Measured: At study entry and at least annually thereafter, until death, withdrawal of consent or end of clinical follow-up (10 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2025
  2. Study start30 Mar 2026
  3. Primary completionJan 2036 (estimated)
  4. Study completionJan 2036 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
50,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07213700
Sponsor's protocol ID
InRAD-AD-OBS-V2.0
Acronym
InRAD
Status last verified
Oct 2026
First submitted
23 Sep 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Pseudonymized individual participant data (IPD) collected through the InRAD data entry system will be shared with InRAD investigators/researchers. Shared IPD will include data from the MDS (minimum data set) and EDS (extended data set)

Publications

  • Perneczky R, Darby D, Frisoni GB, Hyde R, Iwatsubo T, Mummery CJ, Park KH, van Beek J, van der Flier WM, Jessen F. Real-world datasets for the International Registry for Alzheimer's Disease and Other Dementias (InRAD) and other registries: An international consensus. J Prev Alzheimers Dis. 2025 Apr;12(4):100096. doi: 10.1016/j.tjpad.2025.100096. Epub 2025 Feb 18.

    PubMed 39971671

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer's Disease(AD) and Mild Cognitive Impairment (MCI), run by Stichting International Registry for Alzheimer's Disease and other Dementias Foundation at 23 sites in 17 countries.

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 4 inclusion and 2 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Romania, Austria, Greece, Italy, Netherlands and 12 more countries. 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 Scientific Officer (office@inradnetwork.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transitions in Alzheimer's Disease Clinical Stage Over Time (time frame: At study entry and at least annually thereafter, until death, withdrawal of consent or end of clinical follow-up (10 years)). The study lists 2 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 NCT07213700, which also lists 1 linked publication.

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 22 Oct 2026.

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