Status:
TERMINATED
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study
Lead Sponsor:
The George Institute
Collaborating Sponsors:
University of Sydney
Conditions:
Cognitive Decline
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A Sub-Study of an investigator initiated and conducted, multicentre, international, double-blinded, placebo-controlled, parallel-group, randomised controlled trial (TRIDENT) to determine the effect of...
Detailed Description
Cognitive decline and dementia in ICH is high due to the common underlying vasculopathy of cerebral small vessel disease (CSVD). However, in general, detailed cognitive outcomes in ICH have been negle...
Eligibility Criteria
Inclusion
- Eligible for, randomised and continuing in the TRIDENT Main Study
- Must be able to attend the site conducting the cognitive assessments. In Sydney, this will either be at the same site as where TRIDENT study is conducted or at the BMC, University of Sydney, Camperdown.
- Ability and willingness to undergo neuropsychological testing (i.e. have no major visual, auditory or motor impairments)
- Language spoken compatible with CANTAB administration (i.e. CANTAB will be administered in the local language(s) of the country in question. E.g. in Australia, the CANTAB will only be administered in English).
- Provision of written informed consent
Exclusion
- Study medication has been permanently stopped prior to or at the 6-month visit of the TRIDENT main study
- Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) score of 3.313 or higher
- Cognitive performance indicative of dementia at 6-month TRIDENT main study visit defined by Montreal Cognitive Assessment (MoCA) score less than 2414.
- Evidence of rapid deterioration suggestive of dementia by decline of 3 points in MoCA assessments between randomisation and the 6-month study visit in the TRIDENT main study
Key Trial Info
Start Date :
February 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03785067
Start Date
February 27 2020
End Date
February 3 2021
Last Update
April 1 2021
Active Locations (4)
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1
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
2
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
3
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
4
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GC