Observational Study on Determinants of Dementia After Stroke (DEDEMAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ludwig-Maximilians - University of Munich
Sponsor:
Information provided by (Responsible Party):
Martin Dichgans, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01334749
First received: April 12, 2011
Last updated: April 25, 2014
Last verified: April 2014

April 12, 2011
April 25, 2014
April 2011
April 2014   (final data collection date for primary outcome measure)
dementia occurrence [ Time Frame: 60 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01334749 on ClinicalTrials.gov Archive Site
  • dementia occurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • cognitive impairment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • cognitive impairment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • dementia occurrence and cognitive impairment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • dementia occurrence and cognitive impairment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • dementia occurrence and cognitive impairment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 Impairment of some tests of cognitive battery without significant impairment in activities of daily living
  • cognitive impairment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
Not Provided
Not Provided
 
Observational Study on Determinants of Dementia After Stroke
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 60 months.

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).

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 (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. 600 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. 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum, plasma, RNA, CSF

Probability Sample

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

  • Ischemic Stroke
  • Hemorrhagic Stroke
Not Provided
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
Wollenweber FA, Zietemann V, Rominger A, Opherk C, Bayer-Karpinska A, Gschwendtner A, Coloma Andrews L, Bürger 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
April 2019
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 years
  • Language: German
  • Acute stroke that occurred within the last 3 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 living at distance > 30km of the participating center
  • Patients transferred from an outside hospital (to avoid possible selection bias)
  • Patients presenting a stroke going back more than 72 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
Both
18 Years and older
No
Contact: Martin Dichgans, Prof. +49-89-7095 ext 8310 martin.dichgans@med.uni-muenchen.de
Contact: Frank Wollenweber, MD +49-89-7095 ext 8330 frank.wollenweber@med.uni-muenchen.de
Germany
 
NCT01334749
ISD-DEDEMAS-01
No
Martin Dichgans, Ludwig-Maximilians - University of Munich
Ludwig-Maximilians - University of Munich
Not Provided
Principal Investigator: Martin Dichgans, Prof. Institute for Stroke and Dementia Research, Klinikum der Universität München, Campus Großhadern
Ludwig-Maximilians - University of Munich
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP