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NCT Number: NCT00702143

A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

AD:

  • Male or female >=50 years of age
  • Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24

Inclusion criteria

MCI:

  • Male or female >=50 years of age
  • Have a Clinical Dementia Rating (CDR) of 0.5
  • MMSE >24

Normal subjects:

  • Male or female >=50 years of age
  • MMSE >=29
  • Normal on psychometric test battery at screening
  • Provide informed consent

Exclusion criteria

  • Have a history or current diagnosis of other neurologic disease
  • Have had or currently have a diagnosis of other neurodegenerative disease
  • Have participated in experimental therapy targeted to amyloid plaque

Treatment and study plan

florbetapir F 18

Drug

IV injection, 370MBq (10mCi), single dose

Other names: 18F-AV-45, Amyvid, florbetapir

Primary outcomes

  1. Qualitative Amyloid Image Assessment

    Time frame: 50-60 min after injection

    Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.

  2. Mean Cortical to Cerebellum SUVR

    Time frame: 50-60 min after injection

    Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

Secondary outcomes

  1. Proportion of Positive Florbetapir-PET Scans

    Time frame: 50-60 min after injection

    Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 20, 2008
Registry last updated
May 10, 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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