UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051392 |
|---|---|
| Receipt number | R000058627 |
| Scientific Title | Exploration of prevention and treatment of vascular cognitive impairment in patients with asymptomatic carotid artery stenosis/occlusion |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2024/06/20 16:09:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploration of prevention and treatment of vascular cognitive impairment in patients with asymptomatic carotid artery stenosis/occlusion
Acronym
Development of dementia prevention and treatment for patients with asymptomatic carotid artery stenosis/occlusion
Scientific Title
Exploration of prevention and treatment of vascular cognitive impairment in patients with asymptomatic carotid artery stenosis/occlusion
Scientific Title:Acronym
Exploration of prevention and treatment of vascular cognitive impairment in patients with asymptomatic carotid artery stenosis/occlusion
Region
| Japan |
Condition
Condition
Asymptomatic carotid artery stenosis/occlusion
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Asymptomatic carotid artery stenosis/occlusion is not only a major causative disease of cerebral infarction, but also considered to be a causaive disease of vascular cognitive impairment even without cerebral infarction. However, no preventive or therapeutic measures for vascular cognitive impairment caused by asymptomatic carotid artery stenosis/obstruction have been established. Resveratrol, which is commercially available as a dietary supplement, is expected to activate endothelial nitric oxide synthase through activation of SIRT1, a longevity gene, and we will examine whether resveratrol is associated with maintenance of cerebral blood flow plus maintenance/improvement of cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preservation/improvement of cognitive function in patients with asymptomatic carotid artery stenosis/occlusion
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria of patients who visited NCVC between July 2020 and March 2025 were as follows:
(i) Patients with asymptomatic CASO who showed a peak systolic velocity of>130 cm/s at a stenotic lesion or occlusion identified by carotid Doppler ultrasonography.(ii) Patients who underwent neuropsychological examinations including Montreal Cognitive Assessment (MoCA) and Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog). (iii) Patients who underwent also 15O-gas PET.
Key exclusion criteria
Patients deemed by the investigator to be ineligible for participation in this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yorito |
| Middle name | |
| Last name | Hattori |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Neurology
Zip code
564-8565
Address
6-1, Kishibe-shimmachi, Suita, Osaka
TEL
06-6170-1070
yoh2019@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Yorito |
| Middle name | |
| Last name | Hattori |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Neurology
Zip code
564-8565
Address
6-1, Kishibe-shimmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
yoh2019@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Terumo Life Science Foundation, Research Foundation for Dementia of Osaka, Japan Geriatrics Society, Daiwa Securities Health Foundation, Health Science Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, National Cerebral and Cardiovascular Center
Address
6-1, Kishibe-shimmachi, Suita, Osaka
Tel
06-6170-1070
rec-office-ac@ncvc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://j-stroke.org/journal/view.php?doi=10.5853/jos.2023.02733
Number of participants that the trial has enrolled
79
Results
A total of 79 patients were enrolled in this study; 36 received resveratrol and 43 did not. Long-term resveratrol treatment significantly improved visuospatial/executive function (P=0.020) in MoCA, and memory domain (P=0.007) and total score (P=0.019) in ADAS-Cog. Cerebral blood flow demonstrated improvement in the right frontal lobe (P=0.027), left lenticular nucleus (P=0.009), right thalamus (P=0.035), and left thalamus (P=0.010) on 15O-gas PET. No adverse events were reported.
Results date posted
| 2024 | Year | 06 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 26 | Day |
Baseline Characteristics
Participant flow
Patient participation was obtained through an optout methodology, which meant that participants were included in the study unless they expressed their decision to be excluded.
Adverse events
No adverse events were reported.
Outcome measures
Change of cognitive function assessed by MoCA and ADAS-Cog
Change of CBF, CMRO2, and OEF assessed by 15O-gas PET
Plan to share IPD
None
IPD sharing Plan description
N/A
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2024 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058627
