Post-stroke Dementia, Vascular Mild Cognitive ImpairmentPhase 2NCT04572477
The Influence of Sequential Tau Protein and Amyloid Plaque Imaging Changes on Stroke Prognosis and Cognitive Outcome
A Phase 2 study testing [18F]THK-5351 and [18F]AV-45 in people with Post-stroke Dementia, Vascular Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-stroke Dementia, Vascular Mild Cognitive Impairment
- What is being tested?
- [18F]THK-5351 and [18F]AV-45
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2017to 31 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Neurology, Chang-Gung memorial Hospital
Taoyuan, Guishan, 333
Huang Kuo-Lun, M.D., +886-3-3281200 ext. 8340, drkuolun@cgmh.org.tw
About this study
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.
- Being tested
- [18F]THK-5351, [18F]AV-45
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]THK-5351Drug
F-18 THK PET Imaging
[18F]AV-45Drug
F-18 AV45 PET Imaging
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: 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. Receives: Drug: [18F]THK-5351; Drug: [18F]AV-45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1.5 year
Chi-square test will be performed to analyze dementia conversion rate.
Measured: through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Jun 2017
- Primary completion30 Nov 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Dementia, Vascular Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang Kuo-Lun, M.D., Study chair, Stroke Section, Department of Neurology, Chang-Gung memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572477
- Sponsor's protocol ID
- 201601675A0
- Status last verified
- Apr 2023
- First submitted
- 29 Sep 2020
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Sequential Tau Protein and Amyloid Plaque Imaging Changes on Stroke Prognosis and Cognitive Outcome
- ClinicalTrials.gov ID
- NCT04572477
- Acronym / sponsor ID
- 201601675A0
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| [18F]THK-5351 | Other | Drug: [18F]THK-5351, Drug: [18F]AV-451. 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. |
| [18F]AV-45 | Other | Drug: [18F]THK-5351, Drug: [18F]AV-451. 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Inclusion criteria for acute stroke/TIA patients (Group A, n=200)
- Inclusion criteria for chronic stroke/TIA patients (Group B, n=200)
- Inclusion criteria for healthy elderly controls (Group C, n=30)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]THK-5351F-18 THK PET Imaging | Drug | [18F]AV-45, [18F]THK-5351 |
| [18F]AV-45F-18 AV45 PET Imaging | Drug | [18F]AV-45, [18F]THK-5351 |
Primary outcome
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.
Chi-square test will be performed to analyze dementia conversion rate.
Time frame: through study completion, an average of 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang Kuo-Lun, M.D. study chair
Stroke Section, Department of Neurology, Chang-Gung memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]THK-5351 and [18F]AV-45 in people with Post-stroke Dementia, Vascular Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang Kuo-Lun, M.D. (+886-3-3281200 ext. 8340, drkuolun@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging positive and negative conditions (time frame: through study completion, an average of 1.5 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.