A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)
NCT ID: NCT01503944
Last Updated: 2012-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2010-03-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Dementia with Lewy Bodies
18F-AV-133
185 MBq
18F-AV-45
185-370 MBq
Parkinson's disease
18F-AV-133
185 MBq
18F-AV-45
185-370 MBq
Healthy Elderly Volunteers
18F-AV-133
185 MBq
18F-AV-45
185-370 MBq
Alzheimer's Disease
18F-AV-133
185 MBq
18F-AV-45
185-370 MBq
Interventions
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18F-AV-133
185 MBq
18F-AV-45
185-370 MBq
Eligibility Criteria
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Inclusion Criteria
* Meet the diagnostic criteria for probable DLB as established by the DLB Consortium (McKeith et al., 2005)
* Male or female \> 50 years of age
* Meet the NINCDS criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
* Male or female \> 50 years of age
* Have probable PD according to the following criteria (Gelb et al., 1999):
* Presence of 2 of the following 3 features: rest tremor, rigidity, bradykinesia;
* Documented history of a sustained (\>6 months) improvement to Levodopa (L-DOPA) or a dopamine agonist
* Absence of atypical clinical features or other possible signs or symptoms suggesting another cause of parkinsonism such as a history of frequent falls as a prominent early feature, localized brain lesion(s) or neuroleptic use
* Asymmetric onset
* A diagnosis of PD made within the 4 years prior to enrollment
Normal subjects:
* Are males or females \> 50 years of age
* Have a MMSE score \> 29, and are cognitively normal on the psychometric test battery at screening
* Have no signs or symptoms of clinically meaningful parkinsonism
Exclusion Criteria
* Have evidence of clinically significant cerebrovascular disease
* Have evidence from MRI or other biomarker studies that suggests the presence of a CNS pathology other than that associated with the study diseases
50 Years
ALL
Yes
Sponsors
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Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Avid Radiopharmaceuticals
Locations
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Research Site
Sun City, Arizona, United States
Research Site
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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18F-AV-133-B03
Identifier Type: -
Identifier Source: org_study_id