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

Study Overview
=================
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.

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.

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Radiation: SNUBH-NM-333(18F)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amyloid plaque, Positron-Emission Tomography, radiopharmaceuticals