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

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ClinicalTrials.gov Identifier: NCT04572477
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post-stroke Dementia, Vascular Mild Cognitive Impairment Drug: [18F]THK-5351 Drug: [18F]AV-45 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Influence of Sequential Tau Protein and Amyloid Plaque Imaging Changes on Stroke Prognosis and Cognitive Outcome
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
[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.

 Drug: [18F]THK-5351
F-18 THK PET Imaging

Drug: [18F]AV-45
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.

 Drug: [18F]THK-5351
F-18 THK PET Imaging

Drug: [18F]AV-45
F-18 AV45 PET Imaging


Outcome Measures
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Primary Outcome Measures :
  1. Imaging positive and negative conditions [ Time Frame: 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.

  2. Chi-square test will be performed to analyze dementia conversion rate. [ Time Frame: through study completion, an average of 1.5 year ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 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.
  • 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]AV45 or [18F]THK5351.
  • Subjects having high risks for the study according to the PI discretion.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572477


Contacts
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Contact: Huang Kuo-Lun, M.D. +886-3-3281200 ext 8340 drkuolun@cgmh.org.tw
Contact: Chen Jing-Fang +886-3-3281200 ext 8413 tp6tp6fg@gmail.com

Locations
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Taiwan
Department of Neurology, Chang-Gung memorial Hospital Recruiting
Taoyuan, Guishan, Taiwan, 333
Contact: Huang Kuo-Lun, M.D.    +886-3-3281200 ext 8340    drkuolun@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Huang Kuo-Lun, M.D. Stroke Section, Department of Neurology, Chang-Gung memorial Hospital
More Information
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04572477    
Other Study ID Numbers: 201601675A0
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Dementia, Vascular
Plaque, Amyloid
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Dementia
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Pathological Conditions, Anatomical