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

NCT02149017 | Terminated Phase 1 DMC

• 1 other identifier: SNUBH-NM-333(18F)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

amyloid plaque; Positron-Emission Tomography; radiopharmaceuticals

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Standardized uptake value ratio (SUVr)

  Whole-body positron emission tomography /computed tomographic (PET/CT) scans will be performed within 30 days after screening.

Study Arms (1)

SNUBH-NM-333(18F), Safety, Efficacy

EXPERIMENTAL

10 young controls, 10 cognitively normal elderly, and 10 Alzheimer's disease patients

Radiation: SNUBH-NM-333(18F)

Interventions

SNUBH-NM-333(18F) RADIATION

5-10 mCi

SNUBH-NM-333(18F), Safety, Efficacy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sang Eun Kim, MD, PhD

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 29, 2014
• Study Start: December 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2012
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

KR (1)