Status:
COMPLETED
A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
Lead Sponsor:
Avid Radiopharmaceuticals
Conditions:
Alzheimer's Disease
Mild Cognitive Impairment
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).
Eligibility Criteria
Inclusion
- Inclusion Criteria AD:
- Male or female \>=50 years of age
- Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24
- Inclusion Criteria MCI:
- Male or female \>=50 years of age
- Have a Clinical Dementia Rating (CDR) of 0.5
- MMSE \>24
- Normal subjects:
- Male or female \>=50 years of age
- MMSE \>=29
- Normal on psychometric test battery at screening
- Provide informed consent
- Exclusion Criteria:
- Have a history or current diagnosis of other neurologic disease
- Have had or currently have a diagnosis of other neurodegenerative disease
- Have participated in experimental therapy targeted to amyloid plaque
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00702143
Start Date
June 1 2008
End Date
December 1 2008
Last Update
May 10 2012
Active Locations (15)
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1
Research Site
Phoenix, Arizona, United States, 85006
2
Research Site
Scottsdale, Arizona, United States, 85252
3
Research Site
Sun City, Arizona, United States, 85210
4
Research Site
Tucson, Arizona, United States, 85741