UMIN-CTR Clinical Trial

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
Email	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
Email	juri3@kohnan-sendai.or.jp

Sponsor
Institute	Kohnan Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042276