An observational study in Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD), sponsored by Stichting International Registry for Alzheimer's Disease and other Dementias Foundation. Recruiting at 23 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Stichting International Registry for Alzheimer's Disease and other Dementias Foundation · Observational
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:
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.
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:
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):
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):
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 50,000 is above the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →This is the only study on the registry with Stichting International Registry for Alzheimer's Disease and other Dementias Foundation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 6, 2026. See what changed
Participants will be from centers part of the InRAD international network
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-Any patient or legal representative who is unable or unwilling to provide a signed 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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals 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.
Other: None, this is a non-interventional observational study
None applicable
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.
Time frame: At study entry and at least annually thereafter, until death, withdrawal of consent or end of clinical follow-up (10 years)
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.
Time frame: At study entry and at least annually thereafter, until death, withdrawal of consent or end of clinical follow-up (10 years)
Plan to share: 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)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Beginning 1 year after international deployment of the registry platform
Access criteria: Access to IPD is granted to qualified researchers affiliated with participating InRAD Centers. Data requests must be submitted via the InRAD Registry platform and approved by the Scientific Leadership Group (SLG). Approved researchers will receive encrypted, pseudonymized datasets under a Data Use Agreement that ensures confidentiality, secure handling, and deletion after the permitted access period.
Started Mar 2026 (actual). Primary completion is estimated for Jan 2036, 118 months after the start.
Of 364 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's planned 118 months is above that.
Counting every sponsor, half of 405 studies reached it within 67 months; a quarter within 35 and three quarters within 171.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.