Vascular Cognitive ImpairmentCASPERNCT02585349
Cognition and Affect After Stroke: a Prospective Evaluation of Risks
An observational study of Vascular Cognitive Impairment and Post-stroke Depression, run by Maastricht University Medical Center at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Vascular Cognitive Impairment, Post-stroke Depression, Post-stroke Apathy
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2013to 31 Dec 2018
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: first-ever and recurrent ischemic and hemorrhagic stroke patients
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Vascular Cognitive Impairment, Post-stroke Depression, Post-stroke Apathy, Post-stroke Dementia, Vascular Dementia
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| First-ever and recurrent ischemic and hemorrhagic stroke | First-ever and recurrent ischemic and hemorrhagic stroke patients are enrolled in the study. Recurrent strokes are only included if the patient is fully recovered from the previous event, which occurred at least 3 years ago, without obvious residual symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
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.
Measured: 12 months
post-stroke apathy
assessed by the Apathy Evaluation Scale (informant- and clinician rated version is used)
Measured: 12 months
Secondary outcomes (4)
change in cognitive function
slope analyses of neuropsychological trajectories in various cognitive domains
Measured: 12 months
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
Measured: 12 months
change in quality of life
measured with the stroke-specific quality of life scale to evaluate health-related quality of life
Measured: 12 months
change in functional ability
measured with the Barthel Index and Lawton questionnaires
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start1 Apr 2013
- Primary completion31 Oct 2016
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vascular Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Köhler, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585349
- Sponsor's protocol ID
- METC 12-3-068
- Acronym
- CASPER
- Status last verified
- Aug 2022
- First submitted
- 11 Dec 2014
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Douven E, Schievink SH, Verhey FR, van Oostenbrugge RJ, Aalten P, Staals J, Kohler 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/s12883-016-0588-1.
PubMed 27176617Douven E, Kohler 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.
PubMed 28831649Douven E, Kohler 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. Cerebrovasc Dis. 2017;44(5-6):330-337. doi: 10.1159/000481577. Epub 2017 Oct 26.
PubMed 29073590Douven E, Kohler 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: 10.1016/j.jagp.2017.09.022. Epub 2017 Sep 28.
PubMed 29079017Douven E, Aalten P, Staals J, Schievink SHJ, van Oostenbrugge RJ, Verhey FRJ, Kohler S. Co-occurrence of depressive symptoms and executive dysfunction after stroke: associations with brain pathology and prognosis. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):859-865. doi: 10.1136/jnnp-2017-317548. Epub 2018 Feb 8.
PubMed 29439160
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition and Affect After Stroke: a Prospective Evaluation of Risks
- ClinicalTrials.gov ID
- NCT02585349
- Acronym / sponsor ID
- CASPER / METC 12-3-068
- Conditions
- Vascular Cognitive Impairment, Post-stroke Depression, Post-stroke Apathy, Post-stroke Dementia, Vascular Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-ever and recurrent ischemic and hemorrhagic stroke | – | –First-ever and recurrent ischemic and hemorrhagic stroke patients are enrolled in the study. Recurrent strokes are only included if the patient is fully recovered from the previous event, which occurred at least 3 years ago, without obvious residual symptoms. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- first-ever and recurrent ischemic and hemorrhagic stroke patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vascular cognitive impairment
Time frame: 12 months
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
post-stroke depression
Time frame: 12 months
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.
post-stroke apathy
Time frame: 12 months
assessed by the Apathy Evaluation Scale (informant- and clinician rated version is used)
4 secondary outcomes
change in cognitive function
Time frame: 12 months
incident post-stroke dementia
Time frame: 12 months
change in quality of life
Time frame: 12 months
change in functional ability
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Results publication: PubMed 27176617Douven E, Schievink SH, Verhey FR, van Oostenbrugge RJ, Aalten P, Staals J, Kohler 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/s12883-016-0588-1.
- Results publication: PubMed 28831649Douven E, Kohler 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.
- Results publication: PubMed 29073590Douven E, Kohler 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. Cerebrovasc Dis. 2017;44(5-6):330-337. doi: 10.1159/000481577. Epub 2017 Oct 26.
- Results publication: PubMed 29079017Douven E, Kohler 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: 10.1016/j.jagp.2017.09.022. Epub 2017 Sep 28.
- Results publication: PubMed 29439160Douven E, Aalten P, Staals J, Schievink SHJ, van Oostenbrugge RJ, Verhey FRJ, Kohler S. Co-occurrence of depressive symptoms and executive dysfunction after stroke: associations with brain pathology and prognosis. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):859-865. doi: 10.1136/jnnp-2017-317548. Epub 2018 Feb 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Köhler, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Cognitive Impairment and Post-stroke Depression, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vascular cognitive impairment (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585349, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.