The Aging Brain and Cognition: Contribution of Vascular I... | NCT04588649

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
THK-5351	Other	Name: [18F]THK5351，(S)-6-[(3-Fluoro-2-hydroxy)propoxy]-2-(2-Methylaminopyrid-5-yl)-quinoline Dosage form: intravenous injection Dose(s): 10mCi Dosing schedule: Visit 2 Mechanism of action (if known): high affinity radiotracer for the tau protein Pharmacological category：Radio pharmaceutical	Drug: THK-5351 Drug: AV-45
AV-45	Other	Name: [18F]AV-45, (E)-4-(2-(6-(2-(2-(2-[18F]fluoroethoxy) ethoxy) ethoxy)pyridin-3-yl)vinyl)-N-methylbenzenamine Dosage form: intravenous injection Dose(s): 10mCi Dosing schedule: Visit 2 Mechanism of action (if known): high affinity radiotracer for the β- amyloid protein Pharmacological category：Radio pharmaceutical	Drug: THK-5351 Drug: AV-45

Name	Type	Description	Arm Group Labels	Other Names
THK-5351	Drug	[18F]THK-5351 PET Imaging	AV-45 THK-5351

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CDR score of cognition deteriorating group and stable group	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.	through study completion, an average of 1.5 year
Imaging positive and negative conditions	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.	through study completion, an average of 1.5 year

Eligibility Module

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.