COGSCREEN II: Early Detection of Cognitive Impairment

Official title

German: COGSCREEN II: Früherkennung Kognitiver Störungen Durch Screeningverfahren Von Haus- Und Fachärzten Bei Senioren in Deutschland English: COGSCREEN II: Early Detection of Cognitive Impairment Through Screening Procedures by General Practitioners and Specialists in Older Adults in Germany (DAC AccDx Munich Site)

Overview

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

• Behavioral Early Detection
  Blood-based Biomarker Testing

Primary outcome measures

• Percentage of Participants With Alzheimer's Disease Diagnosis Supported by Blood Biomarker Evidence [Time frame: through study completion, an average of 2 year]

Secondary outcome measures (7)

• (Number of) clinician-reported deviations from the standard diagnostic workflow after implementation of Blood Biomarker testing [Time frame: through study completion, an average of 2 year]
• Mean direct diagnostic costs per participant during the diagnostic workup [Time frame: through study completion, an average of 2 year]
• Proportion of correctly classified cases for detection of early Alzheimer's disease using screening modalities [Time frame: through study completion, an average of 2 year]
• Physician acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire [Time frame: through study completion, an average of 2 year]
• Participant acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire [Time frame: Through study completion, an average of 2 year]
• Changes in Clinical Management Following Implementation of the Screening Model [Time frame: through study completion, an average of 2 year]
• Diagnostic Performance and User Acceptance of the BrainChex Digital Cognitive Test Battery [Time frame: through study completion, an average of 2 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

Germany · 1 center

• Klinik für Psychiatrie und Psychotherapie am LMU Klinikum — München

Identifiers

NCT: NCT07466394 · 24-0569_1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗