The Determinants of Dementia After Stroke (DEDEMAS) Study: protocol and pilot data

Authors

  • Frank A. Wollenweber,

    1. Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
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    • Both authors contributed equally to the work.
  • Vera Zietemann,

    1. Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
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    • Both authors contributed equally to the work.
  • Axel Rominger,

    1. Department of Nuclear Medicine, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
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  • Christian Opherk,

    1. Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
    2. Department of Neurology, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
    3. Interdisciplinary Stroke Centre, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
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  • Anna Bayer-Karpinska,

    1. Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
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  • Andreas Gschwendtner,

    1. Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
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  • Lisa Coloma Andrews,

    1. Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
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  • Katharina Bürger,

    1. Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
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  • Marco Duering,

    1. Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
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  • Martin Dichgans

    Corresponding author
    1. Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
    2. Interdisciplinary Stroke Centre, Klinikum der Universität München, Ludwig-Maximilians-University, Munich, Germany
    3. German Center for Neurodegenerative Diseases (DZNE, Munich), Munich, Germany
    4. Munich Cluster for Systems Neurology (SyNergy), Munich, Germany
    • Correspondence: Martin Dichgans, Institute for Stroke and Dementia Research, Klinikum der Universität München, Ludwig-Maximilians-University, Marchioninistr. 15, 81377 Munich, Germany.

      E-mail: martin.dichgans@med.uni-muenchen.de

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  • Conflict of interest:

    Dr. Wollenweber reports no conflicts of interest.

    Dr. Zietemann reports no conflicts of interest.

    Dr. Rominger received support from Bayer, GE and Octapharm AG.

    Dr. Opherk receives research support from the Deutsche Forschungsgemeinschaft and the Dr. Werner Jackstädt Foundation; has served on scientific advisory boards for Boehringer-Ingelheim and Bristol-Myers Squibb and has received speaker honoraria from Bayer, Boehringer-Ingelheim and MSD Sharp Dohme.

    Dr. Bayer-Karpinska reports no conflicts of interest.

    Dr. Gschwendtner reports no conflicts of interest.

    Dr. Coloma Andrews reports no conflicts of interest.

    Dr. Bürger receives speaker honoraria from Novartis and Merz.

    Dr. Duering reports no conflicts of interest.

    Dr. Dichgans receives research support from the European Union, the Deutsche Forschungsgemeinschaft, the BMBF, the German Center for Neurodegenerative Diseases, the Vascular Dementia Research Foundation, the Dr. Werner Jackstädt Foundation, the Corona Foundation, and the Fondation Leducq. He is a consultant to Bayer Vital GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Biologische Heilmittel Heel GmbH; Bristol-Myers Squibb GmbH & Co. KGaA; Ever Neuro Pharma GmbH. He has received honoraria from Bayer Vital GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Biologische Heilmittel Heel GmbH, Ever Neuro Pharma GmbH; Bristol-Myers Squibb GmbH & Co. KGaA, Lundbeck GmbH, Sanofi-Aventis Deutschland GmbH, Shire Deutschland GmbH, UpToDate, W. Kohlhammer GmbH.

Abstract

Rationale

About 20% of stroke patients develop dementia within a few months after their event, but the determinants and mechanisms of poststroke dementia are insufficiently understood.

Aims

To identify and characterize the determinants of cognitive impairment poststroke.

Design

Observational prospective study in patients with acute stroke and no prior dementia. Six hundred subjects will be characterized by detailed interview, standardized clinical examinations, biometric measures (intima-media thickness, waist-hip ratio, and ankle-brachial index), multimodal imaging (magnetic resonance imaging, fluorodeoxyglucose-positron emission tomography (FDG-PET), amyloid-positron emission tomography (amyloid-PET), and retinal imaging), analysis of biomarkers derived from blood and cerebrospinal fluid, and detailed cognitive testing at repeat time points. Patients will be followed for five-years with a total of five personal visits and three telephone interviews.

Study Outcomes

Primary end-point is the occurrence of poststroke dementia. Secondary end-points include poststroke cognitive impairment–no dementia, stroke recurrence, and death. Predictive factors for poststroke dementia will be identified by multiple Cox proportional-hazards model.

Results

Baseline characteristics of the first 71 patients (study inclusion between May 2011 and August 2012) are as follows: median age, 70 years (interquartile range, 65–75); female gender, 25 (35%); median National Institutes of Health Stroke Scale at admission, 2 (1–4); and etiological stroke subtypes according to TOAST classification, 15% large artery disease, 18% small vessel disease, 35% cardioembolic, and 32% undetermined or multiple competing etiologies.

Discussion

This study will provide insights into the mechanisms of poststroke dementia and hold the potential to identify novel diagnostic markers and targets for preventive therapies. The study is registered at http://www.clinicaltrials.gov (NCT01334749) and will be extended as a multicenter study starting 2013.

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