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

Not Applicable

Recruiting

• Conditions: mild cognitive impairment and Alzheimer's disease; Alzheimer's disease

• Registration Number: JPRN-jRCTs031230644
• Lead Sponsor: Tagai Kenji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-19
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified