Back to resultsPhase 1 and Phase 2 Clinical Trials of SNUBH-NM-333(18F)
Primary Purpose
Alzheimer Disease
Status
Terminated
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SNUBH-NM-333(18F)
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease focused on measuring amyloid plaque, Positron-Emission Tomography, radiopharmaceuticals
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SNUBH-NM-333(18F), Safety, Efficacy
Arm Description
10 young controls, 10 cognitively normal elderly, and 10 Alzheimer's disease patients
Outcomes
Primary Outcome Measures
Distribution volume ratio (DVR)
DVR = Distribution volume of region of interest/Distribution volume of reference region
Secondary Outcome Measures
Standardized uptake value ratio (SUVr)
Full Information
NCT ID
NCT02149017
First Posted
May 19, 2014
Last Updated
May 24, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02149017
Brief Title
Phase 1 and Phase 2 Clinical Trials of SNUBH-NM-333(18F)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
SNUH-NM-333 ligand effect was judged to be insufficient.
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
amyloid plaque, Positron-Emission Tomography, radiopharmaceuticals
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SNUBH-NM-333(18F), Safety, Efficacy
Arm Type
Experimental
Arm Description
10 young controls, 10 cognitively normal elderly, and 10 Alzheimer's disease patients
Intervention Type
Radiation
Intervention Name(s)
SNUBH-NM-333(18F)
Intervention Description
5-10 mCi
Primary Outcome Measure Information:
Title
Distribution volume ratio (DVR)
Description
DVR = Distribution volume of region of interest/Distribution volume of reference region
Time Frame
Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Eun Kim, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase 1 and Phase 2 Clinical Trials of SNUBH-NM-333(18F)
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