Post-stroke DementiaPhase 2NCT04588649
The Aging Brain and Cognition: Contribution of Vascular Injury, Amyloid Plaque and Tau Protein to Cognitive Dysfunction After Stroke
A Phase 2 study testing THK-5351 and AV-45 in people with Post-stroke Dementia and Vascular Mild Cognitive Impairment, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Stroke can lead to signficiant neurological deficits, and about one-third of stroke patients will be diagnosed of vascular mild cognitive impairment or post-stroke dementia. Post-stroke dementia includes all types of dementia that happen after stroke, irrespective of their cause, and vascular dementia (VaD)… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-stroke Dementia, Vascular Mild Cognitive Impairment
- What is being tested?
- THK-5351 and AV-45
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jan 2016to 31 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females with age >= 50 years old
- Having cerebral stroke or transient ischemic attack
- Modified Rankin Scale < 4
- 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
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- 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 [24] at the initial screening.
- Presence of large infarction or lobar encephalomalacia on brain CT or MRI.
- Severe language impairment precluding cognitive assessments, defined as a score of 3 points in the language score of the National Institute of Health Stroke Scale.
- Life expectancy less than 1 year.
- Clinically significant abnormal laboratory values.
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- 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 1 year
- 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]AV-45 or [18F]THK-5351.
- Subjects having high risks for the study according to the PI discretion.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Neurology, Chang-Gung memorial Hospital
Taoyuan, Guishan, 333
About this study
Stroke can lead to signficiant neurological deficits, and about one-third of stroke patients will be diagnosed of vascular mild cognitive impairment or post-stroke dementia. Post-stroke dementia includes all types of dementia that happen after stroke, irrespective of their cause, and vascular dementia (VaD), degenerative dementia (especially Alzheimer's disease), or mixed dementia (dementia as a result of the coexistence of vascular lesions of the brain and neurodegenerative lesions) are the most common causes of post-stroke dementia. However, it is difficult to determine to what extent cognitive impairment may be attributable to stroke versus concomitant Alzheimer disease. With the advent of PET imaging technique, we are able to conduct a multi-modal neuroimaging study to explore the composite influence of vascular injury, amyloid plaque and Tau protein the the cognitive performance after stroke.
- Being tested
- THK-5351, AV-45
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THK-5351Drug
[18F]THK-5351 PET Imaging
AV-45Drug
[18F]AV-45 PET Imaging
| Study group | Role | What they receive |
|---|---|---|
| THK-5351 | Other | Name: [18F]THK5351，(S)-6-[(3-Fluoro-2-hydroxy)propoxy]-2-(2-Methylaminopyrid-5-yl)-quinoline Dosage form: intravenous injection Dose(s): 10mCi Dosing schedule: Visit 2 Mechanism of action (if known): high affinity radiotracer for the tau protein Pharmacological category：Radio pharmaceutical Receives: Drug: THK-5351; Drug: AV-45 |
| AV-45 | Other | Name: [18F]AV-45, (E)-4-(2-(6-(2-(2-(2-[18F]fluoroethoxy) ethoxy) ethoxy)pyridin-3-yl)vinyl)-N-methylbenzenamine Dosage form: intravenous injection Dose(s): 10mCi Dosing schedule: Visit 2 Mechanism of action (if known): high affinity radiotracer for the β- amyloid protein Pharmacological category：Radio pharmaceutical Receives: Drug: THK-5351; Drug: AV-45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDR score of cognition deteriorating group and stable group
The CDR is a 5-point scale (0、0.5、1、2、3) used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. The necessary information to make each rating is obtained through a semi-structured interview of the patient and a reliable informant or collateral source (e.g., family member).
Global score 0 = Normal、0.5 = Very Mild Dementia、1 = Mild Dementia、2 = Moderate Dementia、3 = Severe Dementia. The cognition deteriorating group is defined as CDR score declines from 0 or 0.5 at Month 3 to >=1 at Month 18. The cognition stable group is defined as CDR score remains at 0 or 0.5 at Month 18.
Measured: through study completion, an average of 1.5 year
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start4 Jan 2016
- Primary completion29 Mar 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DementiaStudies 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
- * GroupA (Stroke/TIA patients), n=300 * Group (healthy elderly controls), n=30
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588649
- Sponsor's protocol ID
- 103-7584A
- Status last verified
- Sep 2020
- 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 Aging Brain and Cognition: Contribution of Vascular Injury, Amyloid Plaque and Tau Protein to Cognitive Dysfunction After Stroke
- ClinicalTrials.gov ID
- NCT04588649
- Acronym / sponsor ID
- 103-7584A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 29 Mar 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 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.
Stroke can lead to signficiant neurological deficits, and about one-third of stroke patients will be diagnosed of vascular mild cognitive impairment or post-stroke dementia. Post-stroke dementia includes all types of dementia that happen after stroke, irrespective of their cause, and vascular dementia (VaD), degenerative dementia (especially Alzheimer's disease), or mixed dementia (dementia as a result of the coexistence of vascular lesions of the brain and neurodegenerative lesions) are the most common causes of post-stroke dementia. However, it is difficult to determine to what extent cognitive impairment may be attributable to stroke versus concomitant Alzheimer disease. With the advent of PET imaging technique, we are able to conduct a multi-modal neuroimaging study to explore the composite influence of vascular injury, amyloid plaque and Tau protein the the cognitive performance after stroke.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- * GroupA (Stroke/TIA patients), n=300 * Group (healthy elderly controls), n=30
| Arm | Type | Receives |
|---|---|---|
| THK-5351 | Other | Drug: THK-5351, Drug: AV-45Name: [18F]THK5351，(S)-6-[(3-Fluoro-2-hydroxy)propoxy]-2-(2-Methylaminopyrid-5-yl)-quinoline Dosage form: intravenous injection Dose(s): 10mCi Dosing schedule: Visit 2 Mechanism of action (if known): high affinity radiotracer for the tau protein Pharmacological category：Radio pharmaceutical |
| AV-45 | Other | Drug: THK-5351, Drug: AV-45Name: [18F]AV-45, (E)-4-(2-(6-(2-(2-(2-[18F]fluoroethoxy) ethoxy) ethoxy)pyridin-3-yl)vinyl)-N-methylbenzenamine Dosage form: intravenous injection Dose(s): 10mCi Dosing schedule: Visit 2 Mechanism of action (if known): high affinity radiotracer for the β- amyloid protein Pharmacological category：Radio pharmaceutical |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females with age >= 50 years old
- Having cerebral stroke or transient ischemic attack
- Modified Rankin Scale < 4
- 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
Key exclusion criteria (14 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 [24] at the initial screening.
- Presence of large infarction or lobar encephalomalacia on brain CT or MRI.
- Severe language impairment precluding cognitive assessments, defined as a score of 3 points in the language score of the National Institute of Health Stroke Scale.
- Life expectancy less than 1 year.
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 |
|---|---|---|
| THK-5351[18F]THK-5351 PET Imaging | Drug | AV-45, THK-5351 |
| AV-45[18F]AV-45 PET Imaging | Drug | AV-45, THK-5351 |
Primary outcome
CDR score of cognition deteriorating group and stable group
Time frame: through study completion, an average of 1.5 year
The CDR is a 5-point scale (0、0.5、1、2、3) used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care. The necessary information to make each rating is obtained through a semi-structured interview of the patient and a reliable informant or collateral source (e.g., family member). Global score 0 = Normal、0.5 = Very Mild Dementia、1 = Mild Dementia、2 = Moderate Dementia、3 = Severe Dementia. The cognition deteriorating group is defined as CDR score declines from 0 or 0.5 at Month 3 to >=1 at Month 18. The cognition stable group is defined as CDR score remains at 0 or 0.5 at Month 18.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 THK-5351 and AV-45 in people with Post-stroke Dementia and 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 11 inclusion and 14 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDR score of cognition deteriorating group and stable group (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.