Status:
COMPLETED
A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)
Lead Sponsor:
Avid Radiopharmaceuticals
Conditions:
Dementia With Lewy Bodies
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01503944
Start Date
March 1 2010
End Date
July 1 2011
Last Update
August 14 2012
Active Locations (2)
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1
Research Site
Sun City, Arizona, United States
2
Research Site
Philadelphia, Pennsylvania, United States