normal subjects and patients with chronic cerebrovascular disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) healthy Japanese male (20 - 65 years old) (2) body weight < 60 kg (3) informed consent is obtained
Exclusion criteria
Exclusion criteria: (1) metallic implant or claustrophobia (2) chronic disorders (3) CNS, liver, kidney or heart diease (4) acute infection before 30 days (5) drug allergy (6) chronic intake of drugs (> 30 days) (7) other clinical trial (8) screening test (9) willing to have babies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Signal difference of brain parenchyma between pre- and post-administration of PSO17 and saline (2) Temporal signal change after administration of PSO17 and saline | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Efficacy 1) Correlation between blood flow image and PET in patient group (2) Safety 1) Vital signs (BP, HR, body temperature) 2) blood test and urine test 3) adverse effect | — |
Countries
Japan
Contacts
Iwate Medical University Ultrahigh Field MRI