Observational Study on Determinants of Dementia After Stroke

Brief Summary

Official Title: “Determinants of Dementia After Stroke”

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).

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: April 2014

Detailed Clinical Trial 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.

Arms, Groups and Cohorts in this Clinical Trial

  • 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

Outcome Measures for this Clinical Trial

Primary Measures

  • dementia occurrence
    • Time Frame: 60 months
      Safety Issue?: No

Secondary Measures

  • dementia occurrence
    • Time Frame: 6 months
      Safety Issue?: No
  • dementia occurrence
    • Time Frame: 12 months
      Safety Issue?: No
  • dementia occurrence
    • Time Frame: 36 months
      Safety Issue?: No
  • cognitive impairment
    • Time Frame: 36 months
      Safety Issue?: No
  • cognitive impairment
    • Time Frame: 12 months
      Safety Issue?: No
  • cognitive impairment
    • Time Frame: 6 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Ludwig-Maximilians – University of Munich
  • Provider of Information About this Clinical Study
    • Principal Investigator: Martin Dichgans, Prof. Dr. med. M. Dichgans – Ludwig-Maximilians – University of Munich
  • Overall Official(s)
    • Martin Dichgans, Prof., Principal Investigator, Institute for Stroke and Dementia Research, Klinikum der Universität München, Campus Großhadern
  • Overall Contact(s)
    • Martin Dichgans, Prof., +49-89-7095, martin.dichgans@med.uni-muenchen.de

Citations Reporting on Results

Wollenweber FA, Zietemann V, Rominger A, Opherk C, Bayer-Karpinska A, Gschwendtner A, Coloma Andrews L, Bürger K, Duering M, Dichgans M. The Determinants of Dementia After Stroke (DEDEMAS) Study: protocol and pilot data. Int J Stroke. 2014 Apr;9(3):387-92. doi: 10.1111/ijs.12092. Epub 2013 Jul 9.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01334749