Status:
UNKNOWN
The Influence of [18F]PMPBB3 and [18F]THK5351 PET Distribution Patterns on Post-stroke Cognitive Impairment
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Post-stroke Cognitive Impairment
Neuroinflammation
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Background and objects： Neuroinflammation is an active process detectable in the earliest stages of the neurodegeneration pathway. On the other hand, significant neuroinflammation, such as reactive as...
Eligibility Criteria
Inclusion
- Inclusion criteria for acute stroke/TIA patients (Group A, n=50)
- Males or females with age \>= 20 years old.
- Having acute cerebral stroke or transient ischemic attack in recent 1 month.
- Female subjects of childbearing potential must practice effective contraception during the - Provision of signed informed consent from the subject and the subject's legally
- The subject has an appropriate caregiver capable of accompanying the subject, if necessary.
- Inclusion criteria for healthy controls (Group B, n = 30)
- Males or females with age \>= 20 years old
- Without history of cerebral stroke or transient ischemic attack
- Without history of mild cognitive impairment or dementia
- 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
- Exclusion criteria for acute stroke/TIA patients (Group A, n = 50)
- 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 at the initial screening 45.
- 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 3 months.
- 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, such as \[18F\]PMPBB3 or \[18F\]THK5351.
- Subjects having high risks for the study according to the PI discretion.
- Exclusion criteria for healthy controls (Group B, n = 30)
- The Chinese version of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score \>=104 at the initial screening 45.
- 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 3 months.
- 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, such as \[18F\]PMPBB3 or \[18F\]THK5351.
- Subjects having high risks for the study according to the PI discretion.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04318626
Start Date
November 1 2020
End Date
July 31 2024
Last Update
May 1 2023
Active Locations (1)
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1
Department of Neurology, Chang-Gung memorial Hospital
Taoyuan District, Guishan, Taiwan, 333