CSF Dynamic Study of MRI using PSO17

JRCT ID: jRCTs011190003

Registered date:04/07/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Normal pressure hydrocephalus, Alzheimer's disease, other dementia, or mild cognitive impairment
• Date of first enrollment: 13/09/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Intrathecal injection of PSO17.

Outcome(s)

• Primary Outcome: safety
• Secondary Outcome: Evaluation of dynamic changes in O17 concentration measured by MRI signals of CSF.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who admitted Hokkaido University Hospital (department of neurolog y or psychiatry), and suspected of normal pressure hydrocephalus, Alzheimer's disease, other dementia, or minor cognitive impairment.
(2) The patients is scheduled to be performed intrathecal needle insertion (for CSF exam or tap test).
(3) Over 20 years old when informed consent is obtained.
(4) Written informed consent is obtained after sufficient explanation and full understanding

Exclude criteria

(1) Contraindication for MRI such as metallic implant (excluding MRI conditional devises), tatoo in the upper body, or claustrophobia.
(2) Severe lumbar canal stenosis.
(3) Other psychiatric diseases.
(4) Pregnant, suspected pregnancy, plan for pregnancy, refusing contraception including partner, or breast beeding.
(5) Other reason for inadequacy to admit this study judged by principal investigator or co-investigators.

Related Information

• Primary Sponsor: Kudo Kohsuke
• Source(s) of Monetary Support: Japan agency for medical research and development