A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)
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ClinicalTrials.gov Identifier: NCT01503944 |
Recruitment Status
:
Completed
First Posted
: January 4, 2012
Last Update Posted
: August 14, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dementia With Lewy Bodies Alzheimer's Disease Parkinson's Disease | Drug: 18F-AV-133 Drug: 18F-AV-45 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Detection of Striatal Dopaminergic Degeneration and Neocortical Amyloid Pathology in Patients With Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease, and Healthy Elderly Volunteers |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
Dementia with Lewy Bodies |
Drug: 18F-AV-133
185 MBq
Drug: 18F-AV-45
185-370 MBq
|
Parkinson's disease |
Drug: 18F-AV-133
185 MBq
Drug: 18F-AV-45
185-370 MBq
|
Healthy Elderly Volunteers |
Drug: 18F-AV-133
185 MBq
Drug: 18F-AV-45
185-370 MBq
|
Alzheimer's Disease |
Drug: 18F-AV-133
185 MBq
Drug: 18F-AV-45
185-370 MBq
|
- 18F-AV-133 striatal to occipital standard uptake value ratio [ Time Frame: Four Weeks ]The ratio of tracer activity in striatal target areas of interest relative to the occipital cortex reference region
- 18F-AV-45 cortical to cerebellar standard uptake value ratio [ Time Frame: Four Weeks ]The ratio of tracer activity in cortical target areas of interest relative to the cerebellum reference region

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria DLB:
- Male or female > 50 years of age
- Meet the diagnostic criteria for probable DLB as established by the DLB Consortium (McKeith et al., 2005)
Inclusion Criteria AD:
- 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
Inclusion Criteria PD:
- 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 a history or current diagnosis of other neurologic disease
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503944
United States, Arizona | |
Research Site | |
Sun City, Arizona, United States | |
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States |
Study Director: | Chief Medical Officer | Avid Radiopharmaceuticals |
Responsible Party: | Avid Radiopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01503944 History of Changes |
Other Study ID Numbers: |
18F-AV-133-B03 |
First Posted: | January 4, 2012 Key Record Dates |
Last Update Posted: | August 14, 2012 |
Last Verified: | August 2012 |
Additional relevant MeSH terms:
Parkinson Disease Alzheimer Disease Dementia Lewy Body Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Tauopathies Neurocognitive Disorders Mental Disorders |