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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013120

Enrollment

Registered

2014-02-10

Start date

2014-02-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral amyloid angiopathy

Interventions

Non-steroid group Observational period &lt

=18 months 2.5mg prednisolone group Observational period &lt

=18 months, daily administration 10mg prednisolone group Observational period &lt

=18 months, daily administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactTadashi Doden

Aizawa Hospital Department of Neurology

aidr214@ai-hosp.or.jp0263-33-8600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026