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TRIDENT COG

TerminatedPhase 3

Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) Cognitive Sub-Study

Lead sponsor

The George Institute

Asset

telmisartan

Listed sites

Recruiting sites

Enrollment

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•Age ≥18

Primary endpoint

•Memory

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03785067

Org study IDTRIDENT COG

Timeline

Milestones

Study first posted2018-12-24actual

Study start2020-02-27actual

Primary completion2021-02-03actual

Study completion2021-02-03actual

Last update posted2021-04-01actual

Assets

Drug assets

telmisartan

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Memory

1 endpoint

Primary/protocol endpoint

Memory as measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associates Learning (PAL) subtest

Time frame:Baseline, 18 and 36 months

descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Change scores will be computed for CANTAB Rapid Visual Information Processing (RVP)

Time frame:Baseline, 18 and 36 months

descriptive

Secondary/protocol endpoint/low confidence

Change scores will be computed for CANTAB Multi-tasking Test (MTT)

Time frame:Baseline, 18 and 36 months

descriptive

Secondary/protocol endpoint/low confidence

Change scores will be computed for gold-standard neuropsychological assessments

Time frame:Baseline, 18 and 36 months

descriptive

Secondary/protocol endpoint/low confidence

Diagnosis of all-cause dementia

Time frame:36 months

categorical status, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.