COGSCREEN II: Early Detection of Cognitive Impairment

NCT07466394 | Recruiting

• 1 other identifier: 24-0569_1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease (AD)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Alzheimer's Disease Diagnosis Supported by Blood Biomarker Evidence

  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.

  through study completion, an average of 2 year

Secondary Outcomes (7)

• (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

Study Arms (2)

Blood-Based Biomarker Testing

EXPERIMENTAL

Behavioral: Early Detection

No Blood-bases Biomarker Testing

NO INTERVENTION

Interventions

Early Detection BEHAVIORAL

Blood-based Biomarker Testing

Blood-Based Biomarker Testing

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Perneczky: lead
• Davos Alzheimer's Collaborative: collaborator

Study Sites (1)

Klinik für Psychiatrie und Psychotherapie am LMU Klinikum

München, 80336, Germany

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Prof. Dr. Robert Perneczky

CONTACT

+89440055772; robert.perneczky@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Robert Perneczky

Model Details: Cluster-randomized controlled parallel-group interventional study

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 12, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

DE (1)