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

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

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.

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