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Ischemic StrokeDEDEMASNCT01334749

Observational Study on Determinants of Dementia After Stroke

An observational study of Ischemic Stroke and Hemorrhagic Stroke, run by Ludwig-Maximilians - University of Munich at 5 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Hemorrhagic Stroke
How many people
736 participants
Where
5 sitesGermany
Study dates
Apr 2011to Jan 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 9Show fewer
  • An informant of the patient is available
  • Written informed consent by patient prior to study participation
  • Willingness to participate in follow-up

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • DZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité

    Berlin

  • DZNE/Bonn - Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn

    Bonn

  • DZNE/Göttingen - University Medical Center Göttingen

    Göttingen

  • DZNE/Magdeburg - Universitätsklinikum Magdeburg

    Magdeburg

  • DZNE/Munich-Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern

    Munich, Bavaria, 81377

Other trials in Germany

About this study

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 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.

Read the 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.

Keywords
Stroke, Dementia, Dementia, Vascular, Alzheimer's Disease, Intracranial Hemorrhage, Brain Ischemia
Medical subject headings
Ischemic Stroke, Hemorrhagic Stroke, Stroke, Dementia, Dementia, Vascular, Alzheimer Disease, Intracranial Hemorrhages, Brain Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01334749
Study groupRoleWhat they receive
Acute StrokePatients over 18 years and without pre-stroke dementia, displaying an ischemic or hemorrhagic stroke, onset within the last 72 hours, language German

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. dementia occurrence

    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

    Measured: 5 years in DEMDAS

  2. dementia occurrence

    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

    Measured: 10 years in DEDEMAS

Secondary outcomes (7)

  1. dementia occurrence

    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

    Measured: 6 months

  2. dementia occurrence

    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

    Measured: 12 months

  3. dementia occurrence

    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

    Measured: 36 months

  4. cognitive impairment

    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

    Measured: 6 months

  5. cognitive impairment

    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

    Measured: 12 months

  6. cognitive impairment

    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

    Measured: 36 months

  7. cognitive impairment

    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
736 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01334749
Sponsor's protocol ID
ISD-DEDEMAS-01
Acronym
DEDEMAS
Status last verified
Mar 2024
First submitted
12 Apr 2011
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No

Publications

  • Wollenweber FA, Zietemann V, Rominger A, Opherk C, Bayer-Karpinska A, Gschwendtner A, Coloma Andrews L, Burger 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.

    PubMed 23834337

  • Wollenweber FA, Darr S, Muller C, Duering M, Buerger K, Zietemann V, Malik R, Brendel M, Ertl-Wagner B, Bartenstein P, Rominger A, Dichgans M. Prevalence of Amyloid Positron Emission Tomographic Positivity in Poststroke Mild Cognitive Impairment. Stroke. 2016 Oct;47(10):2645-8. doi: 10.1161/STROKEAHA.116.013778. Epub 2016 Aug 18.

    PubMed 27539301

  • Zietemann V, Kopczak A, Muller C, Wollenweber FA, Dichgans M. Validation of the Telephone Interview of Cognitive Status and Telephone Montreal Cognitive Assessment Against Detailed Cognitive Testing and Clinical Diagnosis of Mild Cognitive Impairment After Stroke. Stroke. 2017 Nov;48(11):2952-2957. doi: 10.1161/STROKEAHA.117.017519. Epub 2017 Oct 17.

    PubMed 29042492

  • von Rennenberg R, Nolte CH, Liman TG, Hellwig S, Riegler C, Scheitz JF, Georgakis MK, Fang R, Bode FJ, Petzold GC, Hermann P, Zerr I, Goertler M, Bernkopf K, Wunderlich S, Dichgans M, Endres M; DEMDAS investigators *. High-Sensitivity Cardiac Troponin T and Cognitive Function Over 12 Months After Stroke-Results of the DEMDAS Study. J Am Heart Assoc. 2024 Mar 19;13(6):e033439. doi: 10.1161/JAHA.123.033439. Epub 2024 Mar 8.

    PubMed 38456438

  • Georgakis MK, Fang R, During M, Wollenweber FA, Bode FJ, Stosser S, Kindlein C, Hermann P, Liman TG, Nolte CH, Kerti L, Ikenberg B, Bernkopf K, Poppert H, Glanz W, Perosa V, Janowitz D, Wagner M, Neumann K, Speck O, Dobisch L, Duzel E, Gesierich B, Dewenter A, Spottke A, Waegemann K, Gortler M, Wunderlich S, Endres M, Zerr I, Petzold G, Dichgans M; DEMDAS Investigators. Cerebral small vessel disease burden and cognitive and functional outcomes after stroke: A multicenter prospective cohort study. Alzheimers Dement. 2023 Apr;19(4):1152-1163. doi: 10.1002/alz.12744. Epub 2022 Jul 25.

    PubMed 35876563

  • Arlt FA, Sperber PS, von Rennenberg R, Gebert P, Teegen B, Georgakis MK, Fang R, Dewenter A, Gortler M, Petzold GC, Wunderlich S, Zerr I, Dichgans M, Pruss H, Endres M; DEMDAS Investigators. Serum anti-NMDA receptor antibodies are linked to memory impairment 12 months after stroke. Mol Psychiatry. 2025 Apr;30(4):1359-1368. doi: 10.1038/s41380-024-02744-w. Epub 2024 Oct 30.

    PubMed 39478168

  • Duering M, Adam R, Wollenweber FA, Bayer-Karpinska A, Baykara E, Cubillos-Pinilla LY, Gesierich B, Araque Caballero MA, Stoecklein S, Ewers M, Pasternak O, Dichgans M. Within-lesion heterogeneity of subcortical DWI lesion evolution, and stroke outcome: A voxel-based analysis. J Cereb Blood Flow Metab. 2020 Jul;40(7):1482-1491. doi: 10.1177/0271678X19865916. Epub 2019 Jul 25.

    PubMed 31342832

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Hemorrhagic Stroke, run by Ludwig-Maximilians - University of Munich at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dementia occurrence (time frame: 5 years in DEMDAS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01334749, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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