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)

• Transitions in Alzheimer's Disease Clinical Stage Over Time — At study entry and at least annually thereafter, until death, withdrawal of consent or end of clinical follow-up (10 years)
  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.
• Change in Cognition Over Time — At study entry and at least annually thereafter, until death, withdrawal of consent or end of clinical follow-up (10 years)
  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.

Trial sites (22)

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