Alzheimer's Disease (AD)
Conditions
Brief summary
While knowledge about dementia and its causes is increasing rapidly, healthcare systems remain ill-equipped to detect cognitive decline in the early stages of neurodegenerative diseases such as Alzheimer's disease (AD). However, improving the early identification of AD in the population is a prerequisite for dementia prevention and providing future disease-modifying treatments for individuals most likely to benefit. Subjective cognitive deficits (SCD) and mild cognitive impairment (MCI) may indicate prodromal AD, even in the absence of functional impairment; in conjunction with an AD-typical biomarker profile (such as abnormal protein markers in the cerebrospinal fluid, CSF), the risk of further cognitive decline increases significantly. Offering cognitive screening to individuals with SCD or MCI may therefore open a window of opportunity for early interventions. Currently, there is no system in place for targeted, standardized identification of cases with minimal cognitive decline in Germany or worldwide, hindering efforts to detect neurodegenerative and other causes of cognitive impairment in large segments of the population. The lack of a robust approach for detecting early changes with acceptable accuracy outside of specialist clinics results in disappointingly low diagnostic rates. This is despite evidence showing that structured case finding programs can significantly improve the early detection of cognitive decline. This project will build on an existing network of general practitioners (GPs) and specialists in private practice (neurologists, psychiatrist and geriatricians). The investigator's efforts will aim to strengthen and expand this network, resulting in a larger pool of doctors in the community who have specialized knowledge and a strong commitment to the care of people with dementia. Over the course of the project, the investigators will introduce participating physicians to proprietary digital cognitive tests and blood-based biomarkers (provided by Roche). Building on the success of the ongoing COGSCREEN project, which deploys a community-based recruitment strategy (project number 22-0786), this initiative will equip the Munich healthcare system with the necessary tools to effectively identify individuals most likely to benefit from upcoming disease-modifying treatments for AD. This will serve as a template for the implementation of a precision medicine approach to early diagnosis of AD in Germany and beyond.
Interventions
BEHAVIORALEarly Detection
Blood-based Biomarker Testing
Sponsors
Robert Perneczky
Davos Alzheimer's Collaborative
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Cluster-randomized controlled parallel-group interventional study
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female ≥ 60 years of age at the time of consent * Able to understand and voluntarily sign an informed consent according to the judgment of the practice team
Exclusion criteria
* Subjects who are unable to hear or see well enough to complete the assessments * Prior diagnosis of dementia (with or without evidence of pathology) as documented in the medical record and/or diagnosed by a physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Alzheimer's Disease Diagnosis Supported by Blood Biomarker Evidence | through study completion, an average of 2 year | Proportion of participants diagnosed with Alzheimer's disease whose diagnosis is supported by pathological blood-based biomarker results according to predefined laboratory cut-off values. The outcome will be reported as the percentage of total Alzheimer's disease diagnoses that include biomarker confirmation. |
Secondary
| Measure | Time frame |
|---|---|
| (Number of) clinician-reported deviations from the standard diagnostic workflow after implementation of Blood Biomarker testing | through study completion, an average of 2 year |
| Mean direct diagnostic costs per participant during the diagnostic workup | through study completion, an average of 2 year |
| Proportion of correctly classified cases for detection of early Alzheimer's disease using screening modalities | through study completion, an average of 2 year |
| Physician acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire | through study completion, an average of 2 year |
| Participant acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire | Through study completion, an average of 2 year |
| Changes in Clinical Management Following Implementation of the Screening Model | through study completion, an average of 2 year |
| Diagnostic Performance and User Acceptance of the BrainChex Digital Cognitive Test Battery | through study completion, an average of 2 year |
Countries
Germany
Contacts
CONTACTProf. Dr. Robert Perneczky
Outcome results
None listed