Developing the standard brain templates for iNPH and diagnosing AD comorbid with iNPH

JRCT ID: jRCT1021230047

Registered date:22/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Normal pressure hydrocephalus
• Date of first enrollment: 22/12/2023
• Target sample size: 45
• Study type: Interventional

Intervention(s)

Amyloid beta PET-CT
Brain perfusion SPECT-CT

Outcome(s)

Primary Outcome

(1) Develop the standard brain templates and the brain regions map for iNPH.
(2) Identify which iNPH patients are comorbid with AD using the amyloid beta imaging data of each patient.
(3) Detecting the brain regions in which blood flows are significantly lower, and/or grey and/or white matter volumes are significantly smaller in patients with comorbid AD than those without comorbid AD.

Secondary Outcome

(1) Elucidating the severity differences of gait, coginitive, and urinary disturbances between the iNPH patients with and without comorbid AD.
(2) Detecting the brain lesions with hypoperfusion or atrophy which are associated with gait, cognitive, and/or urinary disturbances in each patients' group (patients with and without comorbid AD).

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

<Patients with iNPH who underwent CSF shunting>
(1) Patients who were 60 or higer and not more than 85 years of age when the informed consents were obtained from the patients and/or their families.
(2) Patients who were diagnosed based on the diagnostic criteria established in accordance with the third edition of the Japanese Clinical Guidelines for iNPH and had ventricular dilatation (Evans' index > 0.3) with a narrow CSF space in the superior convexity (i.e., DESH).
(3) Patients who underwent cranial MRI for the acquitation of three-demensional structural images and 123I-iodoamphetamine single-photon emission computed tomography (brain perfusion SPECT), the Timed Up & Go Test for evaluating gait function, the Mini-Mental State Examination (MMSE) for evaluating general cognitive function, the frontal assessment battery (FAB) for evaluating frontal lobe function, and iNPH Grading Scale (iNPHGS) for assessing the severity of the triad of iNPH before the CSF shunting.
(4) Patients who understood the details of the research and obtained the written informed consents, or patients whose families obtained the written consents If the patients could not understand the details of the research.
<Healthy subjects>
(1) Subjects who were 60 or higer and not more than 85 years of age when the informed consents were obtained from the subjects.
(2) Patients who understood the details of the reserach and obtained the written informed consents.

Exclude criteria

<Patients with iNPH who underwent CSF shunting>
(1) Patients who were comorbid with other neurological diseases except for iNPH and AD.
(2) Patients with a history of mental illness.
(3) Patients with severe complications (malignant tumor, myocardial infarction, heart failure, etc.) that may affect amyloid beta positron emission tomography (PET)-CT.
(4) Patients whose physician judged that it is difficult to perform amyloid beta PET-CT test due to some physical conditions (e.g., allergy to 18F-flutemetamol).
(5) Patiehts whom other persons involved in the reserach (e.g., the researchers) judged to be undesirable as subjects of the research.
<Healthy subjects>
(1) Subjects with a history or comorbidity of neurological diseases.
(2) Subjects with a history of mental illness.
(3) Sublects with severe complications (malignant tumor, myocardial infarction, heart failure, etc.) that may affect brain perfusion SPECT-CT.
(4) Subjects whose physician judged that it is difficult to perform brain perfusion SPECT-CT due to some physical conditions (e.g., allergy to 123I-iodoamphetamine).
(5) Subjcets whom other persons involved in the research (e.g., the researchers) judged to be undesirable as subjects of the research.

Related Information

• Primary Sponsor: Shigenori Kanno
• Source(s) of Monetary Support: Nihon Medi-Physics Co., Ltd.