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Post-stroke Cognitive Impairment

Prediction of Post-stroke Cognitive Decline and Dementia: Impact of Cognitive Reserve and Post-stroke Life Style

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05653141
Acronym
CogStroke
Enrollment
600
Registered
2022-12-16
Start date
2020-12-17
Completion date
2029-10-31
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Performance, First-ever Ischemic Stroke

Keywords

Ischemic stroke, Cognitive reserve

Brief summary

Present study aims to track the post-stroke cognitive trajectories and to investigate its inter-individual variability.

Detailed description

The study aim is to establish a model capturing patients' inter-individual variability in susceptibility to stroke damage to predict stroke-induced cognitive trajectories. This is a prospective longitudinal observational national monocentric study for 6 years (recruitment during the first 3 years). The investigators perform comprehensive neuropsychological testing in i) acute stroke phase (0-10 days post-stroke), ii) sub-acute stroke phase (3 months post-stroke), and iii) chronic stroke phase (12 months and 3 years post-stroke). At each time point, cognitive performances as well as clinical and functional status will be assessed. Furthermore, the investigators will assess the proxies of cognitive reserve and the level of post-stroke physical activity. Analyses of the longitudinal dataset, including follow-up assessments up to 36 months post-stroke, indicated an attrition rate of up to 50%, partly attributable to post-stroke mortality. This level of attrition resulted in a substantial reduction in effective sample size and, consequently, insufficient statistical power for the planned prediction models and independent validation analyses. In particular, the reduced number of complete cases limited the robustness and generalizability of the findings. Therefore, following a recruitment pause on 02.10.2023, patient recruitment was resumed on 05.08.2025 after securing additional funding and dedicated study personnel to ensure adequate sample size for model development and validation.

Interventions

None listed

Sponsors

Roza Umarova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Age ≥18 years old * First-ever anterior circulation ischemic stroke confirmed by routine MRI * Time of enrollment: ≤ 10 days from stroke onset.

Exclusion criteria

* Previous stroke anamnestic or based on clinical imaging * Additional stroke in posterior circulation * Conditions that preclude the cognitive testing (e.g. delirium, intubation, reduced vigilance * Neurological or psychiatric conditions that preclude the data interpretation (e.g. pre-stroke dementia, schizophrenia, brain tumor, regular intake of benzodiazepine, depression) * MRI contraindication * Native language other than German, French or Italian

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with delayed cognitive deterioration (DCD)at 3 months, at 12 months and at 36 months post-strokeThe investigators will assess number of participants with deterioration of the cognitive performance in ≥2 cognitive domains on ≥ 1 Standard Deviation (1 SD).
Number of participants with delayed functional deteriorationat 3 months, at 12 months and at 36 months post-strokeThe investigators will assess number of participants with deterioration of functional disability will be defined as decrease in disability level to one point assessed via modified Rankin Scale (mRS, 0-6, whereas 0=no functional disability).

Secondary

MeasureTime frameDescription
Number of participants with post-stroke cognitive impairment10 days post-stroke, 3 months, 12 months and at 36 months post-strokeThe investigators will assess number of participants with post-stroke cognitive impairment that is defined as at least moderate deficit (performance below -1.5 SD) in ≥ 2 cognitive domains. The cognitive performance across all basic cognitive domains is assessed using a standardized neuropsychological test battery with available normative data. The test battery includes tests from Consortium to Establish a Registry for Alzheimer's Disease (CERAD), Trail Making Test A + B, verbal fluency, alertness test, digit span (forward and backward), Bells test, and Montreal Cognitive Assessment.

Countries

Switzerland

Contacts

CONTACTRoza M. Umarova, PD Dr.
roza.umarova@insel.ch+41316327000
CONTACTLaura Gallucci, MSc
laura.gallucci@extern.insel.ch+41316641506
PRINCIPAL_INVESTIGATORRoza M. Umarova, PD Dr.

Department of Neurology, Inselspital, University Hospital Bern, University of Bern

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026