InRAD Observational Study

NCT07213700 | Recruiting

• 1 other identifier: InRAD-AD-OBS-V1.0
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief 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. The InRAD Registry Observational Study has several aims:

• 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.

Conditions

Alzheimer's Disease(AD); Mild Cognitive Impairment (MCI); Subjective Cognitive Decline (SCD); Non-Alzheimer Degenerative Dementia

Keywords

Alzheimer's disease (AD); Dementia; Observational study; Real-world data (RWD); International registry; Cognitive decline; Lecanemab; InRAD Registry; InRAD Foundation; Cognitive screening (MoCA, MMSE); AD-specific therapies; Clinical staging

Outcome Measures

Primary Outcomes (1)

• Changes in Alzheimer's Disease Clinical Staging over time

  Use of the "Clinical staging for individuals on the Alzheimer's disease continuum" NIA-AA 2018/24 criteria, ranging from Stage 0 to Stage 6: * Stage 0 Asymptomatic, deterministic gene; * Stage 1 Asymptomatic, biomarker evidence only; * Stage 2 Transitional decline: mild detectable change, but 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.

  10 years

Study Arms (1)

Alzheimer's Disease Registry Participants

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

Interventions

None, this is a non-interventional observational study OTHER

None applicable

Alzheimer's Disease Registry Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be from centers part of the InRAD international network

You may qualify if:

• 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

You may not qualify if:

• Any patient or legal representative who is unable or unwilling to provide a signed informed consent form

Sponsors & Collaborators

• Stichting International Registry for Alzheimer's Disease and other Dementias Foundation: lead
• InRAD Foundation (Data Processor): collaborator
• All Individual Principal Investigators and their centers (Data Controllers): collaborator

Study Sites (1)

UZLeuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 39971671 BACKGROUND

Related Links

• InRAD Foundation website

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Scientific Officer

CONTACT

office@inradnetwork.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 9, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

BE (1)