UMIN-CTR Clinical Trial

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

cerebral amyloid angiopathy
isolated cortical venous thrombosis

Classification by specialty

Neurology	Geriatrics	Radiology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Amyloid beta protein deposition with [11C] PiB PET.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kohnan Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kohnan Hospital Ethics Committee

Address

Nagamachi-minami 4-20-1

Tel

+81222482131

Email

m-fuji@kohnan-sendai.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

06

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

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