NCT01334749

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
736

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Apr 2011Jan 2029

Study Start

First participant enrolled

April 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
17.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

17.8 years

First QC Date

April 12, 2011

Last Update Submit

March 18, 2024

Conditions

Ischemic StrokeHemorrhagic Stroke

Keywords

StrokeDementiaDementia, VascularAlzheimer's DiseaseIntracranial HemorrhageBrain Ischemia

Outcome Measures

Primary Outcomes (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

    5 years in DEMDAS

  • 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

    10 years in DEDEMAS

Secondary Outcomes (7)

  • dementia occurrence

    6 months

  • dementia occurrence

    12 months

  • dementia occurrence

    36 months

  • cognitive impairment

    6 months

  • cognitive impairment

    12 months

  • +2 more secondary outcomes

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

Munich, Bavaria, 81377, Germany

Location

DZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité

Berlin, Germany

Location

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

Bonn, Germany

Location

DZNE/Göttingen - University Medical Center Göttingen

Göttingen, Germany

Location

DZNE/Magdeburg - Universitätsklinikum Magdeburg

Magdeburg, Germany

Location

Related Publications (7)

  • 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.

    PMID: 23834337BACKGROUND

  • 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.

    PMID: 27539301RESULT

  • 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.

    PMID: 29042492RESULT

  • 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.

    PMID: 38456438RESULT

  • 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.

    PMID: 35876563RESULT

  • 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.

    PMID: 39478168DERIVED

  • 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.

    PMID: 31342832DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, RNA, CSF

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic StrokeStrokeDementiaDementia, VascularAlzheimer DiseaseIntracranial HemorrhagesBrain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesTauopathiesNeurodegenerative DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Dichgans, Prof.

    Institute for Stroke and Dementia Research, Klinikum der Universität München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. M. Dichgans

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 13, 2011

Study Start

April 1, 2011

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations

DE(5)