Trial record 13 of 33 for:
"Dementia With Lewy Bodies"
A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)
This study has been completed.
Sponsor:
Avid Radiopharmaceuticals
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01503944
First received: July 14, 2010
Last updated: August 3, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Dementia With Lewy Bodies Alzheimer's Disease Parkinson's Disease |
Drug: 18F-AV-133 Drug: 18F-AV-45 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Avid Radiopharmaceuticals:
Primary Outcome Measures:
- 18F-AV-133 striatal to occipital standard uptake value ratio [ Time Frame: Four Weeks ] [ Designated as safety issue: No ]The ratio of tracer activity in striatal target areas of interest relative to the occipital cortex reference region
Secondary Outcome Measures:
- 18F-AV-45 cortical to cerebellar standard uptake value ratio [ Time Frame: Four Weeks ] [ Designated as safety issue: No ]The ratio of tracer activity in cortical target areas of interest relative to the cerebellum reference region
| Enrollment: | 30 |
| Study Start Date: | March 2010 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503944
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
No publications provided
| Responsible Party: | Avid Radiopharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01503944 History of Changes |
| Other Study ID Numbers: | 18F-AV-133-B03 |
| Study First Received: | July 14, 2010 |
| Last Updated: | August 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lewy Body Disease Alzheimer Disease Dementia Parkinson Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders |
ClinicalTrials.gov processed this record on May 21, 2013