Cognition and Affect After Stroke: a Prospective Evaluation of Risks

Vascular Dementia Clinical Trial

— CASPER  

Official title:

Cognition and Affect After Stroke: a Prospective Evaluation of Risks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585349
• Other study ID #: METC 12-3-068
• Status: Completed
• Start date: April 1, 2013
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Stroke is a leading cause of disability, affecting about 34,000 to 41,000 individuals in the Netherlands of middle and old age every year. Due to the aging of the population, this figure will increase considerably over the next decades (Struijs et al., 2005). Twenty-five percent of stroke patients die within one month, making stroke a major risk factor for premature death in developed countries. According to the World Health Organization, stroke is the third leading cause of the burden of disease in middle and high-income countries (World Health Organization, 2008). It has a significant negative impact on quality of life of both the patients as well as their caregivers and significant others. Surviving stroke patients often struggle with its manifold and lifelong lasting consequences, with 35 percent of patients being functionally dependent one year after stroke (Wolfe, 2000) and cognitive and emotional changes which are found up to two years post-stroke (Rasquin, Lodder, & Verhey, 2005). Depression, apathy, and cognitive impairment are very prevalent and significantly contribute to the burden of the disease, but their etiologies remain poorly understood.

The aim of the CASPER study is to gain more insight into the etiologies of post-stroke depression (PSD), post-stroke apathy (PSA), vascular cognitive impairment (VCI), and post-stroke dementia. Therefore, the primary objectives are to identify biomarker-based predictors of PSD, PSA, and VCI. A secondary aim is to study effect modulation, especially the interaction between cerebrovascular disease, neurodegenerative changes and inflammation in post-stroke dementia.

CASPER is a prospective clinical cohort study of 250 first-ever ischemic stroke patients with serial assessments at baseline (10 to 12 weeks after stroke), six and 12 months after baseline. Another wave (36 month after baseline) was later added.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• First-ever or recurrent ischemic or hemorrhagic stroke

• MMSE score =15 (to ensure valid testing)

• Written informed consent

• Sufficient knowledge of the Dutch language

• Preferably participation of an informant

Exclusion Criteria:

• Age younger than 40 years (to exclude atypical strokes)

• Pre-stroke dementia (assessed by a semi-structured interview with a relative, based on clinical diagnosis or IQ-CODE) in the five years prior to stroke

• Psychiatric and neurological disease other than the qualifying event known to affect cognition such as schizophrenia, bipolar disorder, substance abuse, Parkinson's disease, or epilepsy

• Current episode of depression at admission (as evidenced by medical records and patient or informant interview). In contrast, a lifetime history of depression will not be considered as a reason for exclusion as this is considered a potential risk factor for PSD

• Severe aphasia (as it interferes with understanding and following test instructions)

Related Conditions & MeSH terms

• Dementia
• Dementia, Vascular
• Post-stroke Apathy
• Post-stroke Dementia
• Post-stroke Depression
• Stroke
• Vascular Cognitive Impairment
• Vascular Dementia

Locations

Country	Name	City	State
Netherlands	MaastrichtUMC	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

Douven E, Aalten P, Staals J, Schievink SHJ, van Oostenbrugge RJ, Verhey FRJ, Köhler S. Co-occurrence of depressive symptoms and executive dysfunction after stroke: associations with brain pathology and prognosis. J Neurol Neurosurg Psychiatry. 2018 Aug;8 — View Citation

Douven E, Köhler S, Rodriguez MMF, Staals J, Verhey FRJ, Aalten P. Imaging Markers of Post-Stroke Depression and Apathy: a Systematic Review and Meta-Analysis. Neuropsychol Rev. 2017 Sep;27(3):202-219. doi: 10.1007/s11065-017-9356-2. Epub 2017 Aug 22. Rev — View Citation

Douven E, Köhler S, Schievink SHJ, van Oostenbrugge RJ, Staals J, Verhey FRJ, Aalten P. Baseline Vascular Cognitive Impairment Predicts the Course of Apathetic Symptoms After Stroke: The CASPER Study. Am J Geriatr Psychiatry. 2018 Mar;26(3):291-300. doi: — View Citation

Douven E, Köhler S, Schievink SHJ, van Oostenbrugge RJ, Staals J, Verhey FRJ, Aalten P. Temporal Associations between Fatigue, Depression, and Apathy after Stroke: Results of the Cognition and Affect after Stroke, a Prospective Evaluation of Risks Study. — View Citation

Douven E, Schievink SH, Verhey FR, van Oostenbrugge RJ, Aalten P, Staals J, Köhler S. The Cognition and Affect after Stroke - a Prospective Evaluation of Risks (CASPER) study: rationale and design. BMC Neurol. 2016 May 12;16:65. doi: 10.1186/s12883-016-05 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vascular cognitive impairment	defined as a score smaller or equal to 1.5 standard deviations below the general population mean in two or more cognitive domains, based on available norm scores for age, gender and level of education for the Dutch general population	12 months
Primary	post-stroke depression	measured by the Mini International Neuropsychiatric Interview and the Montgomery-Asberg Depression Rating Scale to assess severity. In addition, the Hospital Anxiety and Depression Scale is used to identify levels of anxiety and depression.	12 months
Primary	post-stroke apathy	assessed by the Apathy Evaluation Scale (informant- and clinician rated version is used)	12 months
Secondary	change in cognitive function	slope analyses of neuropsychological trajectories in various cognitive domains	12 months
Secondary	incident post-stroke dementia	diagnosed according to the criteria proposed by the National instate of Neurological Disorders and Strokes - Association Internationale pour la Recherch et l'Enseignement en Neurosciences	12 months
Secondary	change in quality of life	measured with the stroke-specific quality of life scale to evaluate health-related quality of life	12 months
Secondary	change in functional ability	measured with the Barthel Index and Lawton questionnaires	12 months