Investigation for efficacy and safety of [18F] EST-604

JRCT ID: jRCTs031230644

Registered date:19/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: mild cognitive impairment and Alzheimer's disease
• Date of first enrollment: 21/02/2024
• Target sample size: 36
• Study type: Interventional
• Intervention(s): Injection of [18F]EST-604 and PET scan

Outcome(s)

Primary Outcome

(A) Brain kinetic evaluation
Efficacy: Quantitative assessment of [18F]EST-604 brain kinetics and distribution of accumulation in MCI patients, AD patients and healthy adults.
Safety: Changes in subjective symptoms, objective findings, and laboratory tests after administration of [18F]EST-604.
(B) Whole body kinetic evaluation
Effective dose per unit administered radiation dose of [18F] EST-604, Changes in subjective symptoms, objective findings, and clinical examination after administration of [18F] EST-604

Secondary Outcome

(A) Brain kinetic evaluation
Correlations between [18F]EST-604 binding and amyloid and tau accumulation in the brain, brain structural changes, blood data and clinical symptoms in patients with MCI, AD and healthy subjects

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

(A) Brain kinetic evaluation
Healthy adults (10 subjects)
Those who apply voluntarily and are judged by the Principal Investigator, etc. to be capable of understanding the contents of the explanatory documents.
MCI patients (10 subjects ) AD patients (10 subjects)
1. patients who can be accompanied on the day of their participation in the study at the QST by a person who can serve as a surrogate if the patient is unable to give his/her own consent.
2. MCI patients: Patients who meet the diagnostic criteria for mild cognitive impairment due to Alzheimer's disease in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
3. AD patients: Those who meet the diagnostic criteria of dementia due to Alzheimer's disease among the diagnostic criteria of DSM-5.
(B) Whole body kinetic evaluation
Healthy adults (6 subjects)
Those who apply voluntarily and are judged by the Principal Investigator, etc. to be capable of understanding the contents of the explanatory documents.

Exclude criteria

1.Individuals with a history or current presence of organic brain disorders (such as consciousness disorders, head injuries requiring hospitalization, obvious cerebral infarction or hemorrhage).
2.Individuals with substance-related disorders (such as drug dependency).
3.Those with serious complications of diseases, or those with a history of such conditions, deemed inappropriate as subjects for this study by the research physician.
4.Individuals with magnetic metals in the body (including tattoos or permanent makeup, pacemakers, etc.) (for Brain kinetic evaluation only).
5.Individuals with a strong fear of enclosed spaces.
6.Those who are pregnant, might be pregnant, or are breastfeeding.
7.Individuals allergic to local anesthetics and anticoagulants (for Brain kinetic evaluation only).
8.Individuals currently taking anticoagulant medications (for Brain kinetic evaluation only).
9.Others deemed inappropriate as subjects by the research physician.

Related Information

• Primary Sponsor: Tagai Kenji
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology,Japan Agency for Medical Research and Development