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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

Tracking Information
First Submitted Date April 12, 2011
First Posted Date April 13, 2011
Last Update Posted Date August 15, 2019
Actual Study Start Date April 2011
Estimated Primary Completion Date January 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2019)
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: April 12, 2011)
dementia occurrence [ Time Frame: 60 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
Change History Complete list of historical versions of study NCT01334749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 13, 2019)
  • 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
  • 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
  • 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
  • cognitive impairment [ Time Frame: 6 months ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • cognitive impairment [ Time Frame: 12 months ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • cognitive impairment [ Time Frame: 36 months ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • cognitive impairment [ Time Frame: 60 months ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
Original Secondary Outcome Measures
 (submitted: April 12, 2011)
  • dementia occurrence and cognitive impairment [ 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 Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • dementia occurrence and cognitive impairment [ 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 Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • dementia occurrence and cognitive impairment [ 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 Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • cognitive impairment [ Time Frame: 36 months ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study on Determinants of Dementia After Stroke
Official Title Determinants of Dementia After Stroke
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.

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, serum, plasma, RNA, CSF
Sampling Method Probability Sample
Study Population Patients admitted to a specialized stroke service because of an acute stroke.
Condition
  • Ischemic Stroke
  • Hemorrhagic Stroke
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 13, 2019)
736
Original Estimated Enrollment
 (submitted: April 12, 2011)
600
Estimated Study Completion Date January 2029
Estimated Primary Completion Date January 2029   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01334749
Other Study ID Numbers ISD-DEDEMAS-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Martin Dichgans, Ludwig-Maximilians - University of Munich
Study Sponsor Ludwig-Maximilians - University of Munich
Collaborators Not Provided
Investigators
Principal Investigator: Martin Dichgans, Prof. Institute for Stroke and Dementia Research, Klinikum der Universität München
PRS Account Ludwig-Maximilians - University of Munich
Verification Date August 2019