NCGG401-AD

JRCT ID: jRCTs031230338

Registered date:11/09/2023

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Alzheimer's disease
Temporal lobe epilepsy
Glioma

• Date of first enrollment: 30/11/2023
• Target sample size: 55
• Study type: Interventional
• Intervention(s): [11C]NCGG401 injection, flutemetamol (18F) injection, [18F]FDG injection, [11C]DPA-713 injection administration and PET-CT scan, head MRI scan, blood sampling, psychological testing, and magnetoencephalography

Outcome(s)

Primary Outcome

Region-specific differences in distribution volume of [11C]NCGG401 injection solution in the whole brain between cognitively normal subjects and Alzheimer's patients
Regional accumulation of [11C]NCGG401 injection in patients with temporal lobe epilepsy compared to cognitively normal subjects
Focal accumulation of [11C]NCGG401 injection in patients with gliomas compared to cognitively normal subjects

Secondary Outcome

Correlation between the volume of distribution of [11C]NCGG401 injection and cognitive function indices in cognitively normal subjects and Alzheimer's patients.
The association between [11C]NCGG401 accumulation and information of stress including senile plaques in cognitively normal subjects and patients with Alzheimer's disease and temporal lobe epilepsy.
Association between CSF1R density and [11C]NCGG401 accumulation in brain specimens from glioma patients.
Relationship between the local accumulation of [11C]NCGG401 and magnetoencephalography, [18F]FDG distribution, and [11C]DPA-713 distribution

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Cognitively healthy subjects
1)Persons who the principal investigator or subinvestigator (hereinafter referred to as principal investigator, etc.) judges to be capable of understanding the contents of the explanatory document. 2) Persons who are cognitively healthy. 1) Persons who are cognitively healthy
2)Persons who voluntarily applied for the research and obtained written consent to participate in the research.
3)Men and women who are 50 years of age or older at the time of consent
4)Those whose MMSE score is 24 or higher
5)Subjects who scored 9 or higher on the WMS-R Logical Memory II for subjects with 16 or more years of education, 5 or higher for subjects with 10 to 15 years of education, and 3 or higher for subjects with 0 to 9 years of education.

2. Patients with Alzheimer's disease (including patients with less than moderate or mild cognitive impairment)
1)Persons who are judged by the principal investigator to be capable of understanding the consent document
2)Persons who have given written consent to participate in the research
3)Those who are accompanied by a research assistant who is able to grasp and evaluate the subject's situation, and who have obtained the consent of the research assistant.
4)Men and women who are 50 years of age or older at the time of obtaining consent
5)Patients with Alzheimer's disease of moderate severity or less and patients with mild cognitive impairment who meet the clinical diagnostic criteria of NIA-AA (2011)

3. Patients with temporal lobe epilepsy
1)Persons who are judged by the principal investigator to be capable of understanding the consent document
2)Persons who have given written consent to participate in the research
3)Men and women who are 50 years of age or older at the time of consent
4)Patients with a diagnosis of temporal lobe epilepsy
5)Patients who have been taking antiepileptic drugs for less than three month at the time of consent.

4. Glioma patients
1)Persons who are judged by the principal investigator to be able to understand the consent document
2)Persons who have given written consent to participate in the research
3)Men and women who are 50 years of age or older at the time consent is obtained
4)Those who have been diagnosed with gliomas.

Exclude criteria

1. Cognitively normal subjects
1)Patients with developmental and mental health problems that may interfere with the examination
2)Those who have undergone a nuclear medicine examination within 6 months from the time of obtaining consent, from the viewpoint of radiation exposure in nuclear medicine examinations.

2. Patients with gliomas
1)Those who have undergone more than 50% tumor removal, virus-based gene therapy, radiation therapy, bevacizumab, steroids, or anticancer drugs as treatment for gliomas.

3. All subjects
1)Subjects with apparent abnormalities in the medical examination or blood/urine tests at the time of eligibility evaluation, who are judged by the principal investigator, etc. to be at higher than usual risk of adverse health effects due to the PET scan.
2)Subjects who are judged to be unable to suppress their body movements during the examination.
3)Persons with magnetic metals in the body (tattoos, tattoos including art makeup, pacemakers, etc.)
4)Patients with a strong fear of claustrophobia
5)Those with a history of drug allergy
6)Those who are pregnant or may be pregnant, and those who are breast-feeding
7)Subjects with serious complications or those who have a history of serious complications and are judged to be ineligible for this study by the investigators.
8)Those who are regularly taking steroidal and non-steroidal anti-inflammatory drugs or immunosuppressive drugs
9)Participation in a clinical research study involving another intervention, and who have participated in the study for less than one year from the time of the intervention to the time of obtaining consent.
10)Persons who do not consent to the storage of specimens in the Center's biobank.
11)Other subjects who are judged to be ineligible for this study by the principal investigator.

Related Information

• Primary Sponsor: Kimura Yasuyuki
• Source(s) of Monetary Support: National Center for Geriatrics and Gerontology