Observational Study on Determinants of Dementia After Stroke (DEDEMAS)
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Purpose
The primary aim of the DEDEMAS (Determinants of Dementia After Stroke) study is to identify predictors of post stroke dementia (PSD). A particular focus will be on biological markers (neuroimaging, biochemical markers derived from blood) and on interactions between vascular and neurodegenerative mechanisms. For this purpose patients with an acute stroke and without prior dementia will be followed for 60 months.
| Condition |
|---|
|
Ischemic Stroke Hemorrhagic Stroke |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Determinants of Dementia After Stroke |
- dementia occurrence [ Time Frame: 60 months ] [ Designated as safety issue: No ]this evaluation will be based on a neurological and general clinical examination, and on the evaluation of activities of daily life using the instrumental activities daily life scale after an interview with the patient and his/her family
- dementia occurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]this evaluation will be based on a neurological and general clinical examination, and on the evaluation of activities of daily life using the instrumental activities daily life scale after an interview with the patient and his/her family
- dementia occurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]this evaluation will be based on a neurological and general clinical examination, and on the evaluation of activities of daily life using the instrumental activities daily life scale after an interview with the patient and his/her family
- dementia occurrence [ Time Frame: 36 months ] [ Designated as safety issue: No ]this evaluation will be based on a neurological and general clinical examination, and on the evaluation of activities of daily life using the instrumental activities daily life scale after an interview with the patient and his/her family
- cognitive impairment [ Time Frame: 36 months ] [ Designated as safety issue: No ]Impairment of some tests of cognitive battery without significant impairment in activities of daily living
- cognitive impairment [ Time Frame: 12 months ] [ Designated as safety issue: No ]Impairment of some tests of cognitive battery without significant impairment in activities of daily living
- cognitive impairment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Impairment of some tests of cognitive battery without significant impairment in activities of daily living
Biospecimen Retention: Samples With DNA
whole blood, serum, plasma, RNA, CSF
| Estimated Enrollment: | 600 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2019 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Acute Stroke
Patients over 18 years and without pre-stroke dementia, displaying an ischemic or hemorrhagic stroke, onset within the last 72 hours, language German
|
Detailed Description:
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 (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. 600 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. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients admitted to a specialized stroke service because of an acute stroke
Inclusion Criteria:
- Age ≥ 18 years
- Language: German
- Acute stroke that occurred within the last 3 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 living at distance > 30km of the participating center
- Patients transferred from an outside hospital (to avoid possible selection bias)
- Patients presenting a stroke going back more than 72 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
Contacts and Locations| Contact: Martin Dichgans, Prof. | +49-89-7095 ext 8310 | martin.dichgans@med.uni-muenchen.de |
| Contact: Christian Opherk, MD | +49-89-7095 ext 8315 | christian.opherk@med.uni-muenchen.de |
| Germany | |
| Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern | Recruiting |
| Munich, Bavaria, Germany, 81377 | |
| Contact: Martin Dichgans, Prof. +49-89-7095 ext 8310 martin.dichgans@med.uni-muenchen.de | |
| Principal Investigator: Martin Dichgans, Prof. | |
| Principal Investigator: | Martin Dichgans, Prof. | Institute for Stroke and Dementia Research, Klinikum der Universität München, Campus Großhadern |
More Information
Additional Information:
No publications provided
| Responsible Party: | Martin Dichgans, Prof. Dr. med. M. Dichgans, Ludwig-Maximilians - University of Munich |
| ClinicalTrials.gov Identifier: | NCT01334749 History of Changes |
| Other Study ID Numbers: | ISD-DEDEMAS-01 |
| Study First Received: | April 12, 2011 |
| Last Updated: | December 7, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Ludwig-Maximilians - University of Munich:
|
Stroke Dementia Dementia, Vascular |
Alzheimer's Disease Intracranial Hemorrhage Brain Ischemia |
Additional relevant MeSH terms:
|
Dementia Delirium, Dementia, Amnestic, Cognitive Disorders Stroke Cerebral Infarction Intracranial Hemorrhages Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Mental Disorders Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013