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Completed

NCT Number: NCT01565291

A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers

A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Site, Baltimore, Maryland, 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

(AD group):

  • Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Mild/moderate dementia as evidenced by a mini mental state exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
  • History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months

Inclusion criteria

(healthy volunteer group):

  • No evidence of significant cognitive impairment by history and psychometric testing
  • MMSE of 29 or higher

Exclusion criteria

(both groups):

  • Neurodegenerative disorders other than AD
  • Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
  • Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
  • Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
  • Clinically significant psychiatric disease
  • History of epilepsy or convulsions
  • Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
  • Current clinically significant cardiovascular disease
  • Received investigational medication within the last 30 days

Treatment and study plan

florbetapir F 18

Drug

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

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

Primary outcomes

  1. 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 cerebellum gray matter. Total scan length was 200 min.

Secondary outcomes

  1. Precuneus to Cerebellum SUVR

    Time frame: 50-60 min after injection

    Ratio of uptake in the precuneus to uptake in the cerebellum.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

A Preliminary Evaluation of the Amyloid Binding Properties, Pharmacokinetics and Safety of 18F-AV-45 in Healthy Elderly Volunteers and Patients With Alzheimer's Disease

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 28, 2012
Registry last updated
May 18, 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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