The Influence of Sequential Tau Protein and Amyloid Plaque Imaging Changes on Stroke Prognosis and Cognitive Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-stroke Dementia, Vascular Mild Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Group A (acute stroke/TIA patients), n=200 Group B (chronic stroke/TIA patients), n=200 Group C (healthy elderly controls), n=30

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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[18F]THK-5351

1. Primary endpoint A. To compare the distribution of cerebral amyloid plaques and tau protein between stroke patients and normal controls.
2. Secondary endpoints A. To compare tau distribution on \[18F\]THK5351 PET at acute, subacute and chronic stroke stages.

B. To correlate the \[18F\]THK5351 PET findings with \[18F\]AV45 PET, brain MRI, and functional and cognitive performance.

C. To compare the \[18F\]THK5351PET, \[18F\]AV45 PET, and brain MRI findings among stroke patients with no cognitive impairment (NCI), storke patients with VaMCI and stroke patients with PSD.

Group Type OTHER

[18F]THK-5351

Intervention Type DRUG

F-18 THK PET Imaging

[18F]AV-45

Intervention Type DRUG

F-18 AV45 PET Imaging

[18F]AV-45

1. Primary endpoint A. To compare the distribution of cerebral amyloid plaques and tau protein between stroke patients and normal controls.
2. Secondary endpoints A. To compare tau distribution on \[18F\]THK5351 PET at acute, subacute and chronic stroke stages.

B. To correlate the \[18F\]THK5351 PET findings with \[18F\]AV45 PET, brain MRI, and functional and cognitive performance.

C. To compare the \[18F\]THK5351PET, \[18F\]AV45 PET, and brain MRI findings among stroke patients with no cognitive impairment (NCI), storke patients with VaMCI and stroke patients with PSD.

Group Type OTHER

[18F]THK-5351

Intervention Type DRUG

F-18 THK PET Imaging

[18F]AV-45

Intervention Type DRUG

F-18 AV45 PET Imaging

Interventions

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[18F]THK-5351

F-18 THK PET Imaging

Intervention Type DRUG

[18F]AV-45

F-18 AV45 PET Imaging

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

* 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 47.
* 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.
* 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, \[18F\]AV45 or \[18F\]THK5351.
* Subjects having high risks for the study according to the PI discretion.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes