Unique ID issued by UMIN | UMIN000013120 |
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Receipt number | R000015304 |
Scientific Title | Efficacy of steroid therapy for primary prevention of cerebral amyloid angiopathy-related hemorrhage. |
Date of disclosure of the study information | 2014/02/10 |
Last modified on | 2015/05/19 12:25:12 |
Efficacy of steroid therapy for primary prevention of cerebral amyloid angiopathy-related hemorrhage.
Efficacy of steroid therapy for primary prevention of cerebral amyloid angiopathy-related hemorrhage.
Efficacy of steroid therapy for primary prevention of cerebral amyloid angiopathy-related hemorrhage.
Efficacy of steroid therapy for primary prevention of cerebral amyloid angiopathy-related hemorrhage.
Japan |
Cerebral amyloid angiopathy
Neurology |
Others
NO
Cerebral amyloid angiopathy-related hemorrhage typically presents recurrent or multiple lobar hemorrhage. Hypertension and antithrombotic therapy are known as risk factors for hemorrhage in this disorder, but valid prophylactics are still unknown. The efficacy of oral corticosteroid therapy for prevention of re-bleeding has been reported in recent years. We will investigate the efficacy of oral 2.5mg and 10mg prednisolone therapy for preventing hemorrhage in this disorder.
Efficacy
The subjects who had been diagnosed as CAA and agreed with administration of corticosteroid were randomly divided into two groups, 2.5mg and 10mg prednisolone. We will evaluate the time from baseline study to bleeding resulting from CAA within 18 months observational period.
Mini mental state examination, Microbleeds on brain MRI, CSF amyloid beta protein (1-40,1-42) and phosphorylated tau protein, modified Rankin Scale, National Institute of Health Stroke Scale, Functional Independence Measure
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
3
Prevention
Medicine |
Non-steroid group
Observational period <=18 months
2.5mg prednisolone group
Observational period <=18 months, daily administration
10mg prednisolone group
Observational period <=18 months, daily administration
41 | years-old | <= |
86 | years-old | >= |
Male and Female
The subjects are patients who were diagnosed as CAA according to Boston criteria. They should be classified into three groups, probable CAA with supporting pathology, probable CAA or possible CAA with amyloid deposition disclosed by PiB-PET imaging. And the patients who are diagnosed as Alzheimer's disease (AD) with CAA are also included. They should have cognitive impairment consistent with AD, multiple cerebral microbleeds in MRI-T2* weighted image and amyloid deposition in PiB-PET imaging.
Informed consent about the objects, methods, expected results and hazard of this study must be obtained from the patients with CAA.
Patients who have met these exclusion criteria should be excluded.
Age is younger than 41 years old or older than 86 years old when informed consent was obtained.
Patients who have uncontrolled hypertension (systolic blood pressure>=160mmHg or diastolic blood pressure>=100mmHg), taken antithrombotic medication (antiplatelet or anticoagulant drug), abnormal glucose tolerance (HbA1c>=6.5%(NGSP)).
Patients who may have difficulty in adherence to continuous and regular medication.
10
1st name | |
Middle name | |
Last name | Takao Hashimoto |
Aizawa Hospital
Department of Neurology
2-5-1 Honjo, Matsumoto 390-8510, Japan
0263-33-8600
sinke-dr@ai-hosp.or.jp
1st name | |
Middle name | |
Last name | Tadashi Doden |
Aizawa Hospital
Department of Neurology
2-5-1 Honjo, Matsumoto 390-8510, Japan
0263-33-8600
aidr214@ai-hosp.or.jp
Aizawa Hospital
None
Self funding
NO
相澤病院(長野県)
2014 | Year | 02 | Month | 10 | Day |
Unpublished
Terminated
2014 | Year | 01 | Month | 11 | Day |
2014 | Year | 02 | Month | 10 | Day |
2018 | Year | 03 | Month | 31 | Day |
2014 | Year | 02 | Month | 10 | Day |
2015 | Year | 05 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015304
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