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Trial record 1 of 1 for:    NCT01334749
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Observational Study on Determinants of Dementia After Stroke (DEDEMAS)

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ClinicalTrials.gov Identifier: NCT01334749
Recruitment Status : Active, not recruiting
First Posted : April 13, 2011
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Dichgans, Ludwig-Maximilians - University of Munich

Brief Summary:

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 10 years.

Note: Starting from 01.01.2014 this study is expanded to a multi-centric design funded by the German Center for Neurodegenerative Diseases (The DZNE - Mechanisms of Dementia After Stroke (DEMDAS) Study). This includes the following study sites: DZNE/München - Institute for Stroke and Dementia Research, Klinikum der Universität München (Coordinator); DZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité; DZNE/Bonn - Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn; DZNE/Göttingen - University Medical Center Göttingen; DZNE/Magdeburg - Universitätsklinikum Magdeburg.


Condition or disease
Ischemic Stroke Hemorrhagic Stroke

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/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.

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Study Type : Observational
Actual Enrollment : 736 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Dementia After Stroke
Actual Study Start Date : April 2011
Estimated Primary Completion Date : January 2029
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Group/Cohort
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



Primary Outcome Measures :
  1. dementia occurrence [ Time Frame: 5 years in DEMDAS ]
    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

  2. dementia occurrence [ Time Frame: 10 years in DEDEMAS ]
    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


Secondary Outcome Measures :
  1. dementia occurrence [ Time Frame: 6 months ]
    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

  2. dementia occurrence [ Time Frame: 12 months ]
    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

  3. dementia occurrence [ Time Frame: 36 months ]
    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

  4. cognitive impairment [ Time Frame: 6 months ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

  5. cognitive impairment [ Time Frame: 12 months ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

  6. cognitive impairment [ Time Frame: 36 months ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

  7. cognitive impairment [ Time Frame: 60 months ]
    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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to a specialized stroke service because of an acute stroke.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334749


Locations
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Germany
DZNE/Munich-Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern
Munich, Bavaria, Germany, 81377
DZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité
Berlin, Germany
DZNE/Bonn - Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn
Bonn, Germany
DZNE/Göttingen - University Medical Center Göttingen
Göttingen, Germany
DZNE/Magdeburg - Universitätsklinikum Magdeburg
Magdeburg, Germany
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Principal Investigator: Martin Dichgans, Prof. Institute for Stroke and Dementia Research, Klinikum der Universität München

Additional Information:
Publications of Results:
Other Publications:
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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
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

Keywords provided by Martin Dichgans, Ludwig-Maximilians - University of Munich:
Stroke
Dementia
Dementia, Vascular
Alzheimer's Disease
Intracranial Hemorrhage
Brain Ischemia

Additional relevant MeSH terms:
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Stroke
Dementia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders