Clinical trial NCT04588649: The Aging Brain and Cognition: Contribution of Vascular Injury, Amyloid Plaque and Tau Protein to Cognitive Dysfunction After Stroke
Official title: The Aging Brain and Cognition: Contribution of Vascular Injury, Amyloid Plaque and Tau Protein to Cognitive Dysfunction After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-stroke Dementia
Vascular Mild Cognitive Impairment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 181
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * GroupA (Stroke/TIA patients), n=300
* Group (healthy elderly controls), n=30
Primary purpose: DIAGNOSTIC

Brief 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 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 during the 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 during the study and be willing and able to continue contraception after the final study
* Provision of signed informed consent

Exclusion Criteria:

Exclusion criteria for all subjects

* Presence of dementia diagnosis before the index stroke or at the initial screening History 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 3 points 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 at screening or at any date during the study according to the PI discretion) or current breast 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.

Primary outcomes:
measure: CDR score of cognition deteriorating group and stable group
timeFrame: through study completion, an average of 1.5 year
measure: Imaging positive and negative conditions
timeFrame: through study completion, an average of 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Neurology, Chang-Gung memorial Hospital
state: Guishan
Study officials:
References: