Observational Study on Determinants of Dementia After Stroke

Ischemic Stroke Clinical Trial

— DEDEMAS  

Official title:

Determinants of Dementia After Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01334749
• Other study ID #: ISD-DEDEMAS-01
• Status: Active, not recruiting
• Start date: April 2011
• Est. completion date: January 2029

Study information

• Verified date: March 2024
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 736
• Est. completion date: January 2029
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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, Dewent — View Citation

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 a — View Citation

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. — View Citation

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. — View Citation

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 Afte — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	6 months
Secondary	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	12 months
Secondary	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	36 months
Secondary	cognitive impairment	Impairment of some tests of cognitive battery without significant impairment in activities of daily living	6 months
Secondary	cognitive impairment	Impairment of some tests of cognitive battery without significant impairment in activities of daily living	12 months
Secondary	cognitive impairment	Impairment of some tests of cognitive battery without significant impairment in activities of daily living	36 months
Secondary	cognitive impairment	Impairment of some tests of cognitive battery without significant impairment in activities of daily living	60 months

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