Post-stroke Dementia, Vascular Mild Cognitive Impairment
Conditions
Brief summary
Amyloid plaques and tau protein are the landmarks of neurodegeneration in Alzheimer's disease (AD). On the other hand, it is reported that cerebral ischemia may induce amyloid plaques and tau protein accumulation. However, it was difficult to in vivo disentangle the complex and dynamic interactions between AD pathophysiology and cerebral vascular injury in the development of post-stroke cognitive impairment in the past. With the advent of novel radiotracers specific to cerebral amyloid plaques and tau protein, we aim to conduct a prospective multimodal neuroimaging cohort study to investigate the contribution of vascular injury, amyloid plaques and tau protein to stroke recovery and post-stroke cognitive impairment.
Interventions
DRUG[18F]THK-5351
F-18 THK PET Imaging
DRUG[18F]AV-45
F-18 AV45 PET Imaging
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Intervention model description
Group A (acute stroke/TIA patients), n=200 Group B (chronic stroke/TIA patients), n=200 Group C (healthy elderly controls), n=30
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion criteria for acute stroke/TIA patients (Group A, n=200) * Males or females with age \>= 50 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 study and be willing and able to continue contraception after the final study * Provision of signed informed consent 2. Inclusion criteria for chronic stroke/TIA patients (Group B, n=200) * Males or females with age \>= 50 years old * Having cerebral stroke or transient ischemic attack in the past 1.5 years * Having had tau PET imaging study within 1 year after the index stroke/TIA event * 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 3. Inclusion criteria for healthy elderly controls (Group C, n=30) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Imaging positive and negative conditions | through study completion, an average of 1.5 year | PET images are visually assessed by independent raters, who are nuclear medicine doctors and blinded to all clinical and diagnostic information. The raters classify each scan as 0-1 (no significant uptake)、2 (suspicious uptake)、3-4 (significant uptake). The score \>= 2 is deemed as positive condition. |
| Chi-square test will be performed to analyze dementia conversion rate. | through study completion, an average of 1.5 year | — |
Countries
Taiwan
Contacts
Primary ContactHuang Kuo-Lun, M.D.
Backup ContactChen Jing-Fang
Outcome results
None listed