Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT03785067
Eligibility Criteria:
Inclusion Criteria:
1. Eligible for, randomised and continuing in the TRIDENT Main Study
2. 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.
3. Ability and willingness to undergo neuropsychological testing (i.e. have no major visual, auditory or motor impairments)
4. 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).
5. Provision of written informed consent
Exclusion Criteria:
1. Study medication has been permanently stopped prior to or at the 6-month visit of the TRIDENT main study
2. Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) score of 3.313 or higher
3. Cognitive performance indicative of dementia at 6-month TRIDENT main study visit defined by Montreal Cognitive Assessment (MoCA) score less than 2414.
4. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03785067
Study Brief:
Protocol Section:
NCT03785067