NCT04588649

The Aging Brain and Cognition: Contribution of Vascular Injury, Amyloid Plaque and Tau Protein to Cognitive Dysfunction After Stroke

Completed Phase 2 Last updated 6 May 2023

What this trial tests

Phase 2 trial testing THK-5351 in Post-stroke Dementia in 181 participants. Completed in 31 December 2019.

Timeline

4 January 2016

Primary endpoint
29 March 2016

31 December 2019

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	181
Start date	4 January 2016
Primary completion	29 March 2016
Estimated completion	31 December 2019
Sites	1 location across Taiwan

Drugs / interventions tested

• THK-5351 — full drug profile →
• AV-45 — full drug profile →

Conditions studied

• Post-stroke Dementia — all drugs for Post-stroke Dementia →
• Vascular Mild Cognitive Impairment — all drugs for Vascular Mild Cognitive Impairment →

Sponsor

Chang Gung Memorial Hospital

Who can join

50 and older, any sex, with Post-stroke Dementia or Vascular Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stroke can lead to signficiant neurological deficits, and about one-third of stroke patients will be diagnosed of vascular mild cognitive impairment or post-stroke dementia. Post-stroke dementia includes all types of dementia that happen after stroke, irrespective of their cause, and vascular dementia (VaD), degenerative dementia (especially Alzheimer's disease), or mixed dementia (dementia as a result of the coexistence of vascular lesions of the brain and neurodegenerative lesions) are the most common causes of post-stroke dementia. However, it is difficult to determine to what extent cognitive impairment may be attributable to stroke versus concomitant Alzheimer disease. With the advent of PET imaging technique, we are able to conduct a multi-modal neuroimaging study to explore the composite influence of vascular injury, amyloid plaque and Tau protein the the cognitive performance after stroke.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel Tracers and Radionuclides in PET Imaging.
   Mason C, Gimblet GR, Lapi SE, Lewis JS. · · 2021 · cited 10× · PMID 34392925 · DOI 10.1016/j.rcl.2021.05.012
2. Cardiovascular ageing: hallmarks, signaling pathways, diseases and therapeutic targets.
   Zheng P, Yan W, Ding Y, Zhang Y, et al · · 2026 · PMID 42010239 · DOI 10.1038/s41392-026-02630-7