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NCT Number: NCT02205424

Cognition And Neocortical Volume After Stroke

Stroke and dementia are two of the most common and disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment and dementia common after stroke, vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on the contribution of vascular risk factors to Alzheimer's disease. Yet little is known about whether brain volume loss - a hallmark of dementia - occurs after stroke, and whether such atrophy is related to cognitive decline. The aim of this research is to establish whether stroke patients have reductions in brain volume in the first three years post-stroke compared to control subjects, and whether regional and global brain volume change is associated with post-stroke dementia in order to elucidate potential causal mechanisms (including genetic markers, amyloid deposition and vascular risk factors). The hypotheses are that stroke patients will exhibit greater brain volume loss than comparable cohorts of stroke-free controls, and further, that stroke patients who develop dementia will exhibit greater global and regional brain volume loss than those who do not dement. An understanding of whether stroke is neurodegenerative, and in which patients, may be used to help guide the early delivery of disease-modifying therapies.

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Key information

Conditions

Ischaemic Stroke Alzheimer Disease Alzheimer's Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Ischemic Stroke Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Stroke Tauopathies Vascular Dementia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Health, Box Hill, Victoria, Australia

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About this study

Our primary outcome measure was total brain volume (TBV) change between the 3-month and 3-year time-points compared between stroke patients and controls.

Secondary outcome 1 was TBV change between 3-months and 3-years comparing CN and CI stroke participants. TBV at 3-months will be adjusted for CCI scores, and years of education; the latter as it is correlated with cognitive performance and post-stroke dementia risk, but not for stroke lesion volume as no conclusive evidence for an effect has been demonstrated previously.

Secondary outcome 2 was hippocampal volume (HV) change between 3-months and 3-years in stroke patients and controls with adjustments identical to primary outcome.

Secondary outcome 3 was the comparison of HV change between 3-months and 3-years comparing CN and CI stroke participants with adjustments identical to secondary outcome 1.

See published protocol and uploaded statistical analysis plan for detailed description.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical stroke
  • Aged greater than 18 years;
  • Able to have cognitive testing and MRI scan; and
  • Able to give informed consent

Exclusion criteria

  • Significant medical comorbidities precluding participation in cognitive testing, or making survival for three years unlikely;
  • Normal exclusion criteria for MRI; e.g., implanted metal, severe claustrophobia;
  • Pre-existing dementia
  • Pregnancy, as a precaution to prevent exposing them to multiple MRI scans in a 12-month period
  • People in existing dependent or unequal relationships with any member of the research team, to protect against coercion

Treatment and study plan

Primary outcomes

  1. Difference in total brain volume between 3 month and 3 year time-points

    Time frame: Between 3 months and 3 years post-stroke

    We will examine changes in brain volume between the 3 month and 3 year time-points in ischemic stroke patients and healthy age-matched control participants

Secondary outcomes

  1. Comparison of total brain volume (TBV) change between 3 month and 3 year time-points in those who were cognitively normal (CN) versus cognitively impaired (CI) determined at the 3 months post-stroke time point.

    Time frame: Between 3 months and 3 years post-stroke

    Secondary outcome 1 was TBV change between 3-months and 3-years comparing CN and CI stroke participants.

  2. Difference in hippocampal volume between 3 month and 3 year time-points in stroke and control participants.

    Time frame: Between 3 months and 3 years post-stroke

    Secondary outcome 2 was hippocampal volume (HV) change between 3-months and 3-years in stroke patients and controls with adjustments identical to primary outcome.

  3. Comparison of hippocampal volume change between 3 month and 3 year time-points in those who were cognitively normal versus cognitively impaired at 3 months post-stroke.

    Time frame: Between 3 months and 3 years post-stroke

    Secondary outcome 3 was the comparison of HV change between 3-months and 3-years comparing CN and CI stroke participants with adjustments identical to secondary outcome 1.

Sponsors and collaborators

Lead sponsor

The Florey Institute of Neuroscience and Mental Health

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Official study title

Is Stroke Neurodegenerative? A Longitudinal Study of Brain Volume and Cognitive Decline Following Stroke (CANVAS: Cognition And Neocortical Volume After Stroke).

Acronym: CANVAS

Important dates

Study start
2011
Primary completion
2020
Study completion
2021
First posted
Jul 31, 2014
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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