Phase II Study for Amyloid Binding Imaging Study of [18F]AV-45 in Patients With Mild Cognitive Impairment, Alzheimer's Disease and Healthy Volunteers
NCT01238458 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2012-09-28
Summary
This study will recruit a total of 150 evaluable subjects (30 cognitively normal volunteers, and 60 MCI(Mild cognitive impairment), and 60 AD(Alzheimer's disease), respectively) Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.
Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
This study is expected to be completed in a period of 3 years.
Conditions
Interventions
- DRUG
-
[18F]AV-45 PET amyloid binding imaging
This study will recruit a total of 150 evaluable subjects (30 cognitively normal volunteers, and 60 MCI, and 60 AD, respectively) Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
Sponsors & Collaborators
-
Chang Gung Memorial Hospital
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2011-11-30
- Completion
- 2013-06-30
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