InRAD Observational Study

Condition(s) studied

Investigational drug(s) / intervention(s)

None, this is a non-interventional observational study: None applicable

Study 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.

Eligibility

Primary outcome measure(s)

• Changes in Alzheimer's Disease Clinical Staging over time — 10 years
  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.

Trial sites (18)