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

Alzheimer Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02149017
• Other study ID #: SNUBH-NM-333(18F)
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 19, 2014
• Last updated: May 24, 2014
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Radiation:
• SNUBH-NM-333(18F)
5-10 mCi

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution volume ratio (DVR)	DVR = Distribution volume of region of interest/Distribution volume of reference region	Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.	No
Secondary	Standardized uptake value ratio (SUVr)		Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.	No