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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02149017 |
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Date of registration:
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19/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase 1 and Phase 2 Clinical Trials of SNUBH-NM-333(18F)
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Scientific title:
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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. |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT02149017 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Sang Eun Kim, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Bundang Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Intervention(s)
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Radiation: SNUBH-NM-333(18F)
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Primary Outcome(s)
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Distribution volume ratio (DVR)
[Time Frame: Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.]
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Secondary Outcome(s)
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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.]
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Secondary ID(s)
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SNUBH-NM-333(18F)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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