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

NCT04572477 | Unknown Phase 2

• 1 other identifier: 201601675A0
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Dementia, Vascular Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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

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

  through study completion, an average of 1.5 year

Study Arms (2)

[18F]THK-5351

OTHER

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; Drug: [18F]AV-45

[18F]AV-45

OTHER

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; Drug: [18F]AV-45

Interventions

[18F]THK-5351 DRUG

F-18 THK PET Imaging

[18F]AV-45; [18F]THK-5351

[18F]AV-45 DRUG

F-18 AV45 PET Imaging

[18F]AV-45; [18F]THK-5351

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Neurology, Chang-Gung memorial Hospital

Taoyuan District, Guishan, 333, Taiwan

RECRUITING

MeSH Terms

Interventions

THK5351; florbetapir

Study Officials

• Huang Kuo-Lun, M.D.

  Stroke Section, Department of Neurology, Chang-Gung memorial Hospital

  STUDY CHAIR

Central Study Contacts

Huang Kuo-Lun, M.D.

CONTACT

+886-3-3281200; drkuolun@cgmh.org.tw

Chen Jing-Fang

CONTACT

+886-3-3281200; tp6tp6fg@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 1, 2020
• Study Start: June 1, 2017
• Primary Completion: November 30, 2023
• Study Completion: May 31, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-04

Locations

TW (1)