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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Alzheimer Disease
Dementia
Lewy Body Disease
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Tauopathies

ClinicalTrials.gov processed this record on November 24, 2014