UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037101 |
|---|---|
| Receipt number | R000042276 |
| Scientific Title | Prospective study on evaluation of amyloid accumulation in patients suspected of both cerebral amyloid angiopathy and isolated cortical venous thrombosis using Amyloid positron emission tomography |
| Date of disclosure of the study information | 2019/06/20 |
| Last modified on | 2020/07/22 17:14:40 |
* 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
Prospective study on evaluation of amyloid accumulation in patients suspected of both cerebral amyloid angiopathy and isolated cortical venous thrombosis using Amyloid positron emission tomography
Acronym
ALPS-VACANCES
Scientific Title
Prospective study on evaluation of amyloid accumulation in patients suspected of both cerebral amyloid angiopathy and isolated cortical venous thrombosis using Amyloid positron emission tomography
Scientific Title:Acronym
ALPS-VACANCES
Region
| Japan |
Condition
Condition
cerebral amyloid angiopathy
isolated cortical venous thrombosis
Classification by specialty
| Neurology | Geriatrics | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are patients who have low signal lesion with T2* weighted image along on the surface of brain which is associated with local neurological symptoms without cortical multiple microhemorrhages typical for CAA. Such cases could be diagnosed as both CAA and isolated cerebral cortical venous thrombosis (ICVT). The purpose of this study is to evaluate the differences in the pathogenesis of ICVT and CAA, focusing on the degree of cerebral amyloid deposition using amyloid PET.
Basic objectives2
Others
Basic objectives -Others
Cerebral amyloid deposition using amyloid PET
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amyloid beta protein deposition with [11C] PiB PET.
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
1) T2* weighted image demonstrates linear low intensities along surface of the brain.
2) Neurological symptoms (including transient) correlate with the cortical linear lesions in T2* weighted image.
3) Two or more physicians diagnose that multiple cortical micro bleeds in the cerebrum or cerebellum are not conspicuous on T2* weighted image.
4) The score of Mini Mental State Examination is not matter.
5) Age and gender do not matter.
6) The written informed consent is obtained from the patient or representative.
Key exclusion criteria
1. Highly suspected with CAA
2. Diagnosed as Alzheimer's disease
3. Contraindication for MRI (pacemaker, brain clip etc)
4. Inappropriate cases to participate in this study judged by the physicians.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Itabashi |
Organization
Kohnan Hospital
Division name
Department of Stroke Neurology
Zip code
9828523
Address
Nagamachiminami 4-20-1, Taihakuku, Sendai, Miyagi, Japan
TEL
022-248-2131
rmkitabash@gmail.com
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Kobayashi |
Organization
Kohnan Hospital
Division name
Department of Stroke Neurology
Zip code
9828523
Address
Nagamachiminami 4-20-1, Taihakuku, Sendai, Miyagi, Japan
TEL
0222482131
Homepage URL
juri3@kohnan-sendai.or.jp
Sponsor or person
Institute
Kohnan Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kohnan Hospital Ethics Committee
Address
Nagamachi-minami 4-20-1
Tel
+81222482131
m-fuji@kohnan-sendai.or.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
| 2019 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
4
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There are patients with linear low signal lesions along the brain surface on MRI T2* weighted image accompanied with local neurologic symptoms associated with them. In these patients, cerebral or cerebellar cortical microbleeds which are typical in patients with cerebral amyloid angiopathy (CAA) is inconspicuous. Such cases can be ether CAA with amyloid spell or isolated cortical venous thrombosis (ICVT). In this study, amyloid PET imaging (amyloid PET) would be performed on such cases to evaluate the status of amyloid beta protein deposition. The purpose of this study is to address the differences in the pathogenesis of ICVT and CAA, focusing on the degree of cerebral amyloid deposition. Based on the anatomical information of MRI image, the SUVR (SUV value on amyloid PET of cerebral cortex is divided by the one of cerebellum) was calculated. In addition, we would obtain control data from patients with Alzheimer's disease and healthy elderly people used in previous research. SUVR were compared among three groups (20 patients with Alzheimer's disease, 20 healthy controls and 10 patients in this study).
Management information
Registered date
| 2019 | Year | 06 | Month | 18 | Day |
Last modified on
| 2020 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042276
