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

Phase

Condition

Stroke

Dementia

Cerebral Ischemia

Treatment

THK-5351

AV-45

Clinical Study ID

NCT04588649

103-7584A

Ages > 50
All Genders
Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Inclusion criteria for stroke/TIA patients

Males or females with age >= 50 years old
Having cerebral stroke or transient ischemic attack
Modified Rankin Scale < 4
Ability to participate in cognitive and neuroimaging assessments
Female subjects of childbearing potential must practice effective contraception duringthe study and be willing and able to continue contraception after the final study
Provision of signed informed consent Inclusion criteria for healthy elderly controls
Males or females with age >= 50 years old
Without history of cerebral stroke or transient ischemic attack
Ability to participate in cognitive and neuroimaging assessments
Female subjects of childbearing potential must practice effective contraception duringthe study and be willing and able to continue contraception after the final study
Provision of signed informed consent

Exclusion

Exclusion Criteria: Exclusion criteria for all subjects

Presence of dementia diagnosis before the index stroke or at the initial screeningHistory of vascular MCI (VaMCI)
The Chinese version of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score >=104 [24] at the initial screening.
Presence of large infarction or lobar encephalomalacia on brain CT or MRI.
Severe language impairment precluding cognitive assessments, defined as a score of 3points in the language score of the National Institute of Health Stroke Scale.
Life expectancy less than 1 year.
Clinically significant abnormal laboratory values.
Clinically significant or unstable medical or psychiatric illness.
Epilepsy history.
Cognitive impairment resulting from trauma or brain damage.
Substance abuse or alcoholism in the past 1 year
General MRI, and / or PET exclusion criteria.
Pregnant or becoming pregnant during the study (as documented by pregnancy testing atscreening or at any date during the study according to the PI discretion) or currentbreast feeding.
History of allergy to 18F-labelled radionucleic agents, [18F]AV-45 or [18F]THK-5351.
Subjects having high risks for the study according to the PI discretion.

Study Design

THK-5351

January 04, 2016

December 31, 2019

Connect with a study center

Department of Neurology, Chang-Gung memorial Hospital
Taoyuan, Guishan 333
Taiwan
Site Not Available

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