JPRN-jRCT1030230229Recruiting未知
Invasive cerebral small vessel function assessment study for HTRA1-related cerebral small vessel disease including CARASI
Onodera Osamu0 sites25 target enrollmentStarted: July 14, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Other
Eligibility Criteria
- Ages
- >= 20age old to < 80age old (—)
Inclusion Criteria
- •The patient group is defined as those between 20 and 80 years of age with confirmed HTRA1 mutation or with clinical symptoms and imaging findings consistent with HTRA1-associated cerebral small vessel disease in second-degree relatives of HTRA1 mutation-positive patients.
- •The healthy group is those who are between 20 and 80 years of age and have not been clinically diagnosed with dementia.
Exclusion Criteria
- •1) Patients who have been treated with a prohibited concomitant drug within the last 12 weeks prior to enrollment.
- •2) Patients who have initiated or changed the dosage of a prohibited concomitant medication within the past 4 weeks prior to enrollment.
- •3) Patients with active infections requiring systemic treatment
- •4) Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2)
- •5) Patients with severe hepatic impairment (AST (GOT) or ALT (GPT) > 100 U/L)
- •6) Patients with abnormal serum sodium or potassium levels requiring therapeutic correction.
- •7) Patients with a 12-lead ECG showing QT prolongation or shortening requiring therapeutic correction.
- •8) Patients with a history of cerebral infarction, intracranial hemorrhage, transient ischemic attack, or cerebral aneurysm with a high probability of rupture diagnosed within the last 12 weeks prior to enrollment.
- •9) Patients being treated for or with a history of coronary artery disease (angina, myocardial infarction).
- •10) Patients with poorly controlled respiratory disease (asthma, chronic obstructive pulmonary disease, etc.)
- •11) Patients with occlusion or significant stenosis of the main intracranial artery or carotid artery
- •12) Patients with systolic blood pressure below 100 mmHg
- •13) Patients with pulse rate less than 45 beats/minute or greater than 120 beats/minute
- •14) Patients with drug abuse or alcoholism
- •15) Patients unable to obtain an adequate head MR scan
- •16) Patients with active malignant neoplastic disease
- •17) Patients who are pregnant, lactating, or who may become pregnant between the date of informed consent and the date of study completion.
- •18) Patients who have participated in other studies involving the administration of investigational products within 24 weeks prior to enrollment.
- •19) Other patients deemed ineligible for the study by the investigator or others.
Investigators
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