Phase 1 and Phase 2 Clinical Trials of SNUBH-NM-333(18F)

Phase 1 and Phase 2 Clinical Trials for the Evaluation of Pharmacokinetics, Safety, and Efficacy of SNUBH-NM-333(18F) in Alzheimer's Disease Patients and Healthy Volunteers.

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02149017

Enrollment

Registered

2014-05-29

Start date

2010-12-31

Completion date

2012-12-31

Last updated

2014-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

amyloid plaque, Positron-Emission Tomography, radiopharmaceuticals

Brief summary

To evaluate pharmacokinetics, safety and efficacy of SNUBH-NM-333(18F), a new diagnostic radiopharmaceutical for PET imaging of amyloid plaques, in Alzheimer's disease patients and healthy volunteers.

Detailed description

The investigators will perform whole-body and brain kinetic modeling of SNUBH-NM-333(18F) and optimize the image acquisition procedure. Five young healthy subjects will be participated in Whole-body positron emission tomography /computed tomographic (PET/CT) scans from the midfemoral position to the head after approximately 5-10 mCi of SNUBH-NM-333(18F) injection. For brain PET/CT amyloid imaging, another five young healthy subjects will be scanned dynamically during windows of 0-180 min after injection of SNUBH-NM-333(18F), with arterial sampling. The investigators will compare different analysis methods of compartmental modeling and standardized uptake value ratios and determine the optimal acquisition window. And then 10 AD patients and 10 elderly healthy controls will also be participated in brain amyloid imaging to compare SNUBH-NM-333(18F) brain retention in AD patients versus healthy elderly.

Interventions

RADIATIONSNUBH-NM-333(18F)

5-10 mCi

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy young controls who are 20 - 30 years old and have no subjective memrory complaints * Cognitively normal elderly who have Clinical Dementia Rating score of 0 * Alzheimer's disease (AD) patients who met both the DSM-IV criteria for dementia and NINCDS-ADRDA criteria for probable AD

Exclusion criteria

* any present serious medical, psychiatric, or neurological disorder that could affect mental function; evidence of focal brain lesions on MRI; the presence of severe behavioral or communication problems

Design outcomes

Primary

Measure	Time frame	Description
Distribution volume ratio (DVR)	Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.	DVR = Distribution volume of region of interest/Distribution volume of reference region

Secondary

Measure	Time frame
Standardized uptake value ratio (SUVr)	Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026