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Completed

NCT Number: NCT01503944

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site, Sun City, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-AV-133

Drug

185 MBq

18F-AV-45

Drug

185-370 MBq

Primary outcomes

  1. 18F-AV-133 striatal to occipital standard uptake value ratio

    Time frame: Four Weeks

    The ratio of tracer activity in striatal target areas of interest relative to the occipital cortex reference region

Secondary outcomes

  1. 18F-AV-45 cortical to cerebellar standard uptake value ratio

    Time frame: Four Weeks

    The ratio of tracer activity in cortical target areas of interest relative to the cerebellum reference region

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 4, 2012
Registry last updated
Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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