Ignite Creation Date:
2024-05-05 @ 11:27 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01334749
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2011-04-12
Brief Title:
Observational Study on Determinants of Dementia After Stroke
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Determinants of Dementia After Stroke
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEDEMAS
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 01012014 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 DZNEMünchen - Institute for Stroke and Dementia Research Klinikum der Universität München Coordinator DZNEBerlin - Neuroscience Research Center - Campus Mitte Charité DZNEBonn - Klinik und Poliklinik für Neurologie Universitätsklinikum Bonn DZNEGöttingen - University Medical Center Göttingen DZNEMagdeburg - Universitätsklinikum Magdeburg
Note Starting from 01012014 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 DZNEMünchen - Institute for Stroke and Dementia Research Klinikum der Universität München Coordinator DZNEBerlin - Neuroscience Research Center - Campus Mitte Charité DZNEBonn - Klinik und Poliklinik für Neurologie Universitätsklinikum Bonn DZNEGöttingen - University Medical Center Göttingen DZNEMagdeburg - Universitätsklinikum Magdeburg
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 DEDEMASDEMDAS 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 Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None