Observational Study on Determinants of Dementia After Stroke (DEDEMAS)

March 18, 2024 updated by: Martin Dichgans, Ludwig-Maximilians - University of Munich

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 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.

Study Overview

Status

Active, not recruiting

Conditions

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

Enrollment (Actual)

736

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • DZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité
      • Bonn, Germany
        • DZNE/Bonn - Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn
      • Göttingen, Germany
        • DZNE/Göttingen - University Medical Center Göttingen
      • Magdeburg, Germany
        • DZNE/Magdeburg - Universitätsklinikum Magdeburg
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • DZNE/Munich-Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients admitted to a specialized stroke service because of an acute stroke.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years in DEMDAS
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
10 years in DEDEMAS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
12 months
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
36 months
cognitive impairment
Time Frame: 6 months
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
6 months
cognitive impairment
Time Frame: 12 months
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
12 months
cognitive impairment
Time Frame: 36 months
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
36 months
cognitive impairment
Time Frame: 60 months
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

  • Principal Investigator: Martin Dichgans, Prof., Institute for Stroke and Dementia Research, Klinikum der Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (Estimated)

April 13, 2011

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISD-DEDEMAS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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