search
Back to results

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

Primary Purpose

Post-stroke Dementia, Vascular Mild Cognitive Impairment

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
[18F]THK-5351
[18F]AV-45
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post-stroke Dementia, Vascular Mild Cognitive Impairment

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Neurology, Chang-Gung memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

[18F]THK-5351

[18F]AV-45

Arm Description

Primary endpoint A. To compare the distribution of cerebral amyloid plaques and tau protein between stroke patients and normal controls. 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.

Primary endpoint A. To compare the distribution of cerebral amyloid plaques and tau protein between stroke patients and normal controls. 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.

Outcomes

Primary Outcome Measures

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.
Chi-square test will be performed to analyze dementia conversion rate.

Secondary Outcome Measures

Full Information

First Posted
September 29, 2020
Last Updated
May 2, 2023
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04572477
Brief Title
The Influence of Sequential Tau Protein and Amyloid Plaque Imaging Changes on Stroke Prognosis and Cognitive Outcome
Official Title
The Influence of Sequential Tau Protein and Amyloid Plaque Imaging Changes on Stroke Prognosis and Cognitive Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Dementia, Vascular Mild Cognitive Impairment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
Investigator
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F]THK-5351
Arm Type
Other
Arm Description
Primary endpoint A. To compare the distribution of cerebral amyloid plaques and tau protein between stroke patients and normal controls. 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.
Arm Title
[18F]AV-45
Arm Type
Other
Arm Description
Primary endpoint A. To compare the distribution of cerebral amyloid plaques and tau protein between stroke patients and normal controls. 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.
Intervention Type
Drug
Intervention Name(s)
[18F]THK-5351
Intervention Description
F-18 THK PET Imaging
Intervention Type
Drug
Intervention Name(s)
[18F]AV-45
Intervention Description
F-18 AV45 PET Imaging
Primary Outcome Measure Information:
Title
Imaging positive and negative conditions
Description
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.
Time Frame
through study completion, an average of 1.5 year
Title
Chi-square test will be performed to analyze dementia conversion rate.
Time Frame
through study completion, an average of 1.5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Kuo-Lun, M.D.
Phone
+886-3-3281200
Ext
8340
Email
drkuolun@cgmh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Jing-Fang
Phone
+886-3-3281200
Ext
8413
Email
tp6tp6fg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huang Kuo-Lun, M.D.
Organizational Affiliation
Stroke Section, Department of Neurology, Chang-Gung memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurology, Chang-Gung memorial Hospital
City
Taoyuan
State/Province
Guishan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Kuo-Lun, M.D.
Phone
+886-3-3281200
Ext
8340
Email
drkuolun@cgmh.org.tw

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs