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

May 2, 2023 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Guishan
      • Taoyuan, Guishan, Taiwan, 333
        • Recruiting
        • Department of Neurology, Chang-Gung memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: [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
Other: [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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Huang Kuo-Lun, M.D., Stroke Section, Department of Neurology, Chang-Gung memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201601675A0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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