A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the ability to identify individuals with dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from Alzheimer's disease (AD) and control subjects.

Official Title
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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

Conditions
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Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease

Intervention / Treatment
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* Drug: 18F-AV-133
* Drug: 18F-AV-45


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dementia with Lewy Bodies<br> | Drug: 18F-AV-133<br>* 185 MBq<br>Drug: 18F-AV-45<br>* 185-370 MBq<br>|
| Other: Parkinson's disease<br> | Drug: 18F-AV-133<br>* 185 MBq<br>Drug: 18F-AV-45<br>* 185-370 MBq<br>|
| Other: Healthy Elderly Volunteers<br> | Drug: 18F-AV-133<br>* 185 MBq<br>Drug: 18F-AV-45<br>* 185-370 MBq<br>|
| Other: Alzheimer's Disease<br> | Drug: 18F-AV-133<br>* 185 MBq<br>Drug: 18F-AV-45<br>* 185-370 MBq<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-AV-133 striatal to occipital standard uptake value ratio | The ratio of tracer activity in striatal target areas of interest relative to the occipital cortex reference region | Four Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-AV-45 cortical to cerebellar standard uptake value ratio | The ratio of tracer activity in cortical target areas of interest relative to the cerebellum reference region | Four Weeks |