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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503944
• Other study ID #: 18F-AV-133-B03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 14, 2010
• Last updated: August 3, 2012
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2012
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• 18F-AV-133
185 MBq
• 18F-AV-45
185-370 MBq

Locations

Country	Name	City	State
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Sun City	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No