Overview

This trial is active, not recruiting.

Conditions ischaemic stroke, alzheimer's disease, vascular dementia
Sponsor The Florey Institute of Neuroscience and Mental Health
Collaborator National Health and Medical Research Council, Australia
Start date May 2011
End date December 2017
Trial size 175 participants
Trial identifier NCT02205424, APP-1020526

Summary

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 we still know very little 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). We hypothesise 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients who have suffered an ischaemic stroke, as determined clinically and verified with imaging (CT brain; MRI).
People who have never suffered a stroke, and are matched to the ischaemic stroke patient group according to age, education, and vascular risk factors.

Primary Outcomes

Measure
Dementia diagnoses in a proportion of stroke patients three years post-stroke
time frame: Three years post-stroke

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Clinical stroke 2. Aged greater than 18 years; 3. Able to have cognitive testing and MRI scan; and 4. Able to give informed consent Exclusion Criteria: 1. Significant medical comorbidities precluding participation in cognitive testing, or making survival for three years unlikely; 2. Normal exclusion criteria for MRI; e.g., implanted metal, severe claustrophobia; 3. Pre-existing dementia 4. Pregnancy, as a precaution to prevent exposing them to multiple MRI scans in a 12-month period 5. People in existing dependent or unequal relationships with any member of the research team, to protect against coercion

Additional Information

Official title Is Stroke Neurodegenerative? A Longitudinal Study of Brain Volume and Cognitive Decline Following Stroke (CANVAS: Cognition And Neocortical Volume After Stroke).
Principal investigator Amy G Brodtmann, MBBS PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by The Florey Institute of Neuroscience and Mental Health.