DEDEMAS: Observational Study on Determinants of Dementia After Stroke

Sponsor

Ludwig-Maximilians - University of Munich (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01334749

Collaborator

(none)

736

Enrollment

Locations

213.1

Anticipated Duration (Months)

147.2

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Hemorrhagic Stroke

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 Design

Study Type:

Observational

Actual Enrollment :

736 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Determinants of Dementia After Stroke

Actual Study Start Date :

Apr 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2029

Anticipated Study Completion Date :

Jan 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

dementia occurrence [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
dementia occurrence [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

Secondary Outcome Measures

dementia occurrence [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
dementia occurrence [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
dementia occurrence [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
cognitive impairment [6 months]
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
cognitive impairment [12 months]
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
cognitive impairment [36 months]
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
cognitive impairment [60 months]
Impairment of some tests of cognitive battery without significant impairment in activities of daily living

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DZNE/Munich-Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern	Munich	Bavaria	Germany	81377
2	DZNE/Berlin - Neuroscience Research Center - Campus Mitte Charité	Berlin		Germany
3	DZNE/Bonn - Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn	Bonn		Germany
4	DZNE/Göttingen - University Medical Center Göttingen	Göttingen		Germany
5	DZNE/Magdeburg - Universitätsklinikum Magdeburg	Magdeburg		Germany