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DEDEMASDeterminants of Dementia After Stroke

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Ischemic Stroke+23

+ Hemorrhagic Stroke

+ Alzheimer Disease

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2011
See protocol details

Summary

Principal SponsorLudwig-Maximilians - University of Munich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

Risk of dementia is high after stroke but the mechanisms of post stroke dementia (PSD) are insufficiently understood. Specifically, there are few data on how vascular and neurodegenerative mechanisms interact in determining cognitive decline after stroke. The primary aim of the DEDEMAS/DEMDAS (Determinants of Dementia After Stroke) study is to identify predictors of PSD. A particular focus will be on biological markers (neuroimaging, biochemical markers derived from blood) and on interactions between vascular and neurodegenerative mechanisms. Patients with an acute stroke and without prior dementia will be followed for 5 years with assessments at baseline (< 72 h after onset of stroke), and at 3, 6, 12, 24, 36, 48, and 60 months. In addition, DEDEMAS patients will have an annual telephone follow-up from year 6 to 10. Baseline assessments will include variables previously demonstrated to be associated with PSD as well as novel variables. Brain MRI (structural MRI and resting state fMRI) in combination with detailed neuropsychological testing and blood draws will be done at 6, 12, 36, and 60 months. Patients developing cognitive impairment (with or without dementia) and a subgroup of matched individuals without cognitive decline will be examined by brain FDG-PET and Amyloid-PET scanning. Lumbar puncture will be done on patients who develop cognitive impairment and thus have a clinical indication for the procedure. Efforts will be made to classify demented patients into diagnostic categories (Vascular Dementia, Mixed Dementia, Alzheimer's disease, other categories). Predictive factors for PSD will be identified using multiple Cox-proportional hazards models. Apart from providing insights into the mechanisms of PSD this study holds the potential to identify novel diagnostic markers and novel targets for preventive therapies.

Official TitleDeterminants of Dementia After Stroke
NCT01334749
Principal SponsorLudwig-Maximilians - University of Munich
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

736 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ischemic StrokeHemorrhagic StrokeAlzheimer DiseaseArterial Occlusive DiseasesArteriosclerosisMental DisordersBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesIntracranial ArteriosclerosisBrain IschemiaCerebrovascular DisordersDementiaHemorrhageNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesDementia, VascularNeurodegenerative DiseasesNeurocognitive DisordersIntracranial HemorrhagesStrokeIntracranial Arterial DiseasesTauopathiesLeukoencephalopathies

Criteria

Inclusion Criteria: * Age ≥ 18 years * Language: German * Acute stroke that occurred within the last 5 days as defined by: acute focal neurological deficit in combination with one of the following: * An acute ischemic infarct as documented by either a DWI positive lesion on MR imaging or a new lesion on a delayed CT scan * An intracerebral hemorrhage as documented on CT or MRI * An informant of the patient is available * Written informed consent by patient prior to study participation * Willingness to participate in follow-up Exclusion Criteria: * IQCODE \> 64 or diagnosis of dementia * Patients transferred from an outside stroke unit (to avoid possible selection bias) * Patients presenting a stroke going back more than 120 hours * Patients presenting one of the following diseases: cerebral venous thrombosis, traumatic cerebral haemorrhage, intracerebral haemorrhage because of a known or image-guided assumed vascular malformation, pure meningeal or intraventricular haemorrhage * Patients presenting a malignant disease with life expectancy \< 3years * Contraindication for MRI * Participation in an intervention/AMG-study at baseline

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

DZNE/Munich-Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern

Munich, GermanyOpen DZNE/Munich-Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern in Google Maps
Suspended

DZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité

Berlin, Germany
Suspended

DZNE/Bonn - Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn

Bonn, Germany
Suspended

DZNE/Göttingen - University Medical Center Göttingen

Göttingen, Germany
Suspended5 Study Centers