Post-stroke Dementia, Vascular Mild Cognitive Impairment
Conditions
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.
Interventions
DRUGTHK-5351
\[18F\]THK-5351 PET Imaging
DRUGAV-45
\[18F\]AV-45 PET Imaging
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Intervention model description
* GroupA (Stroke/TIA patients), n=300 * Group (healthy elderly controls), n=30
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CDR score of cognition deteriorating group and stable group | through study completion, an average of 1.5 year | The CDR is a 5-point scale (0、0.5、1、2、3) used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. The necessary information to make each rating is obtained through a semi-structured interview of the patient and a reliable informant or collateral source (e.g., family member). Global score 0 = Normal、0.5 = Very Mild Dementia、1 = Mild Dementia、2 = Moderate Dementia、3 = Severe Dementia. The cognition deteriorating group is defined as CDR score declines from 0 or 0.5 at Month 3 to \>=1 at Month 18. The cognition stable group is defined as CDR score remains at 0 or 0.5 at Month 18. |
| 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. |
Countries
Taiwan
Outcome results
None listed