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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arizona
Research Site
Sun City, Arizona, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Avid Radiopharmaceuticals

Investigators

Study Director:	Chief Medical Officer	Avid Radiopharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT01503944 History of Changes
Other Study ID Numbers:	18F-AV-133-B03
First Posted:	January 4, 2012
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