In vivo comparison within the enantiomers of [18F]PM-PBB3

JRCT ID: jRCTs031190114

Registered date:21/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: mild cognitive impairment, Alzheimer's disease, progressive supranuclear palsy, and so on.
• Date of first enrollment: 04/12/2019
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Injection of [18F]PMPBB3 and PET scan

Outcome(s)

Primary Outcome

(efficacy) Differeces of pharmacokinetics, distibution of volume, quantification, and off-target binding among the enantiomers of [18F]PM-PBB3
(safety) Effective dose of the favoranble enantiomers of [18F]PM-PBB3 in human

• Secondary Outcome: (efficacy) Clinical effects of [18F]PM-PBB3 in human

Key inclusion & exclusion criteria

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

Include criteria

(efficacy) Healthy subjects and subjects with mild cognitive impairment, Alzheimer's disease, progressive supranuclear palsy, corticobasal syndrome or frontotemporal degeneration over 20 years of age
(safety) Healthy subjects over 50 years of age

Exclude criteria

(efficacy)
1.Subjects with any organic brain disorder.
2.Subjects with any substance-related disorders.
3.Subjects who has a serious disease complication or history.
4.Subjects with metallic medical device in the body.
5.Subjects with tattoo.
6.Subjects with severe claustrophobia.
7.Subjects with pregnancy or breastfeeding.
8.Subjects who has participated in other study in recent 6 months.
9.Subjects with a history of allergy to heparin and local anesthetics.(applied to (efficacy))
10.Subjects who has taken anticoagulants. (applied to (efficacy))
11.Subjects who is considered to be inappropriate to participate in the study.

(safety)
1.Subjects with any organic brain disorder.
2.Subjects with any substance-related disorders.
3.Subjects who has a serious disease complication or history.
4.Subjects with metallic medical device in the body.
5.Subjects with tattoo.
6.Subjects with severe claustrophobia.
7.Subjects with pregnancy or breastfeeding.
8.Subjects who has participated in other study in recent 6 months.
9.Subjects who is considered to be inappropriate to participate in the study.

Related Information

• Primary Sponsor: Takado Yuhei