Observational Study on Determinants of Dementia After Stroke (DEDEMAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ludwig-Maximilians - University of Munich
Sponsor:
Information provided by (Responsible Party):
Martin Dichgans, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01334749
First received: April 12, 2011
Last updated: April 25, 2014
Last verified: April 2014
  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.

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).


Condition
Ischemic Stroke
Hemorrhagic Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Dementia After Stroke

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334749

Contacts
Contact: Martin Dichgans, Prof. +49-89-7095 ext 8310 martin.dichgans@med.uni-muenchen.de
Contact: Frank Wollenweber, MD +49-89-7095 ext 8330 frank.wollenweber@med.uni-muenchen.de

Locations
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.         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
Principal Investigator: Martin Dichgans, Prof. Institute for Stroke and Dementia Research, Klinikum der Universität München, Campus Großhadern
  More Information

Additional Information:
Publications:
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: April 25, 2014
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
Stroke
Cerebral Infarction
Intracranial Hemorrhages
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014