Investigation for efficacy of [18F]FEDAC

JRCT ID: jRCTs031220375

Registered date:12/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dementia-related disorders, Neuroinflammation-related neuropsychiatric disorders
• Date of first enrollment: 26/01/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Injection of [18F]FEDAC and PET scan

Outcome(s)

Primary Outcome

Accuracy of measurement of [18F]FEDAC brain kinetics and distribution volume in patients with dementia-related diseases, neuroinflammation-related psychiatric diseases, and healthy subjects
Individual differences in accumulation of [18F]FEDAC in trunk organs by genetic polymorphisms in patients with dementia-related disorders, neuroinflammation-related psychiatric disorders, and healthy subjects.

• Secondary Outcome: Association of [18F]FEDAC accumulation in the brain with data of MRI, blood biomarkers and clinical evaluations

Key inclusion & exclusion criteria

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

Include criteria

Healthy subjects
1. Be 20 years of age or older at the time of consenting to participate in this study.
2. Subjects must be able to give consent to participate in this study and must be able to read and understand the consent document.

Dementia-related disorders
1.Patients who are 20 years of age or older at the time of consent.
2. Patients diagnosed with MCI or AD.
The diagnostic criteria for each disease shall be as follows.
(1)MCI: Patients who meet Petersen's diagnostic criteria.
(2)AD: Patients who meet the diagnostic criteria of NINCDS-ADRDA.
3.Patients who have the capacity to consent to participation in this study and are able to read and understand the consent document. The patient must be able to read and understand the consent document or, if the patient is incapable of consenting, be accompanied on the day of participation by a person who can serve as a substitute consentor.

Neuroinflammation-related neuropsychiatric disorders
1.20 years of age or older at the time consent is obtained.
2.Patients diagnosed with mood disorder (depression, bipolar disorder) or Long COVID.
The diagnostic criteria for each disease shall be as follows
(1) Mood disorder (depression, bipolar disorder): Patients who meet the diagnostic criteria for depression in DSM-5 or who have met the diagnostic criteria for a depressive episode of bipolar disorder.
(2) Long COVID: Persons with clinical symptoms that correspond to Long COVID as defined in the "COVID-19 Clinical Practice Guide: Management of Post Morbidity Symptoms, 1st Edition.
3. Have the capacity to consent to participate in this study. Subjects who are able to read and understand the consent document.

Exclude criteria

Healthy subjects
1. Subjects with a history of or with complications from organic brain diseases (e.g., impaired consciousness, head trauma requiring hospitalization, apparent cerebral infarction, cerebral hemorrhage, etc.)
2.Subjects with complications of substance-related disorders (drug dependence, etc.)
3. Subjects who have a complication of a serious disease, or who have a history of such a complication and the principal investigator or sub-investigator (hereinafter referred to as "principal investigator, etc.") determines that they are inappropriate as subjects of this study.
4.Subjects who have magnetic metals in their bodies (tattoos, tattoos including art makeup, pacemakers, etc.)
5.Subjects who have a strong fear of claustrophobia
6.Pregnant or possibly pregnant, or breast-feeding.
7.Subjects who are allergic to local anesthetics and blood coagulation inhibitors.
8. Subjects taking anticoagulant drugs.
9.Subjects who are taking dietary supplements or health supplements from 10 hours prior to blood collection for blood biomarker analysis to immediately prior to blood collection.
10. Subjects who is participating in a clinical trial.
11.Subjects deemed inappropriate by the Principal Investigator or others.

Dementia-related disorders
1.Subjects who have a history of or are suffering from organic cerebral diseases (such as impaired consciousness, head trauma requiring hospitalization, apparent cerebral infarction, cerebral hemorrhage, etc.)
2.Subjects with complications of substance-related disorders (drug dependence, etc.)
3. Subjects who have a complication of a serious disease, or who have a history of such a complication and are judged by the principal investigator, etc. to be inappropriate as subjects for this study.
4. Subjects who have magnetic metals in their bodies (tattoos, tattoos including art makeup, pacemakers, etc.)
5. Subjects who have a strong fear of claustrophobia
6. pregnant or possibly pregnant, or breast-feeding.
7. Subjects who are allergic to local anesthetics and blood coagulation inhibitors
8. Subjects taking anticoagulant drugs.
9. Subjects who are taking dietary supplements or health supplements from 10 hours prior to blood collection for blood biomarker analysis to immediately prior to blood collection.
10. Subjects who is participating in a clinical trial.
11. Subjects who deemed inappropriate by the Principal Investigator or others.

Neuroinflammation-related neuropsychiatric disorders
1. Subjects who have a history of or are complicated by organic cerebral diseases (such as impaired consciousness, head trauma requiring hospitalization, apparent cerebral infarction, or hemorrhage, etc.)
2.Subjects with complications of substance-related disorders (drug dependence, etc.)
3.Subjects who have a complication of a serious disease, or who have a history of such a complication and are judged by the principal investigator, etc. to be inappropriate as subjects for this study.
4.Subjects who have magnetic metals in their bodies (tattoos, including tattoos and art makeup, metals in their bodies such as pacemakers, brain clips, and bolts, etc.)
5. Subjects with a strong fear of claustrophobia.
6. Subjects with strong suicidal tendencies.
7. Subjects who are pregnant or
Pregnant, possibly pregnant, or breast-feeding.
8. Subjects who are allergic to local anesthetics and blood coagulation inhibitors
9. Subjects taking anticoagulant drugs.
10.Subjects taking dietary supplements or health supplements from 10 hours prior to blood collection for blood biomarker analysis to immediately prior to blood collection.
11. Subjects who is participating in a clinical trial.
12.Subjects deemed inappropriate by the principal investigator.

Related Information

• Primary Sponsor: Takahata Keisuke