InRAD Observational Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorStichting International Registry for Alzheimer's Disease and other Dementias Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Participants will be from centers part of the InRAD international network

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • None, this is a non-interventional observational study

    Other intervention

    None applicable

Treatment groups

50,000 Participants
are divided into 1 treatment group
Group A: Alzheimer's Disease Registry Participants1 intervention

Trial outcomes

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.

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stichting International Registry for Alzheimer's Disease and other Dementias Foundation

Lead sponsor

InRAD Foundation (Data Processor)

Collaborator

Principal Investigator

Collaborator