Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:25 PM
Study NCT ID:
NCT07466394
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COGSCREEN II: Early Detection of Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster-randomized controlled parallel-group interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-07', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-07', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants With Alzheimer's Disease Diagnosis Supported by Blood Biomarker Evidence", 'timeFrame': 'through study completion, an average of 2 year', 'description': "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."}], 'secondaryOutcomes': [{'measure': '(Number of) clinician-reported deviations from the standard diagnostic workflow after implementation of Blood Biomarker testing', 'timeFrame': 'through study completion, an average of 2 year'}, {'measure': 'Mean direct diagnostic costs per participant during the diagnostic workup', 'timeFrame': 'through study completion, an average of 2 year'}, {'measure': "Proportion of correctly classified cases for detection of early Alzheimer's disease using screening modalities", 'timeFrame': 'through study completion, an average of 2 year'}, {'measure': "Physician acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire", 'timeFrame': 'through study completion, an average of 2 year'}, {'measure': "Participant acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire", 'timeFrame': 'Through study completion, an average of 2 year'}, {'measure': 'Changes in Clinical Management Following Implementation of the Screening Model', 'timeFrame': 'through study completion, an average of 2 year'}, {'measure': 'Diagnostic Performance and User Acceptance of the BrainChex Digital Cognitive Test Battery', 'timeFrame': 'through study completion, an average of 2 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease (AD)"]}, 'descriptionModule': {'briefSummary': "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.\n\nCurrently, 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥ 60 years of age at the time of consent\n* Able to understand and voluntarily sign an informed consent according to the judgment of the practice team\n\nExclusion Criteria:\n\n* Subjects who are unable to hear or see well enough to complete the assessments\n* Prior diagnosis of dementia (with or without evidence of pathology) as documented in the medical record and/or diagnosed by a physician'}, 'identificationModule': {'nctId': 'NCT07466394', 'acronym': 'COGSCREEN II', 'briefTitle': 'COGSCREEN II: Early Detection of Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '24-0569_1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood-Based Biomarker Testing', 'interventionNames': ['Behavioral: Early Detection']}, {'type': 'NO_INTERVENTION', 'label': 'No Blood-bases Biomarker Testing'}], 'interventions': [{'name': 'Early Detection', 'type': 'BEHAVIORAL', 'description': 'Blood-based Biomarker Testing', 'armGroupLabels': ['Blood-Based Biomarker Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80336', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Klinik für Psychiatrie und Psychotherapie am LMU Klinikum', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'centralContacts': [{'name': 'Prof. Dr. Robert Perneczky', 'role': 'CONTACT', 'email': 'robert.perneczky@med.uni-muenchen.de', 'phone': '+89440055772'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Perneczky', 'class': 'OTHER'}, 'collaborators': [{'name': "Davos Alzheimer's Collaborative", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Robert Perneczky', 'investigatorFullName': 'Robert Perneczky', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}