DEDEMASDeterminants of Dementia After Stroke
Data Collection
Collected from today forward - ProspectiveIschemic Stroke+23
+ Hemorrhagic Stroke
+ Alzheimer Disease
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.736 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
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
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 MapsDZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité
Berlin, GermanyDZNE/Bonn - Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn
Bonn, GermanyDZNE/Göttingen - University Medical Center Göttingen
Göttingen, Germany