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

May 24, 2014 updated by: Jong Inn Woo, Seoul National University Hospital

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SNUBH-NM-333(18F), Safety, Efficacy
10 young controls, 10 cognitively normal elderly, and 10 Alzheimer's disease patients
Radiation: SNUBH-NM-333(18F)
5-10 mCi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution volume ratio (DVR)
Time Frame: 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
Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Sang Eun Kim, MD, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 24, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 24, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-NM-333(18F)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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