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Completed

NCT Number: NCT01265394

Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects

Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GE Healthcare

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The subject age is 18 to 40 years.
  • The subject has no evidence of thinking or memory problems by medical history.
  • The subject has a normal MRI scan.
  • The subject's general health is adequate to comply with study procedures.
  • The subject is willing and able to participate in all study procedures.

Exclusion criteria

  • The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
  • The subject has a contraindication for (cannot undergo) MRI.
  • The subject has a history of head injury with loss of consciousness.
  • The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
  • The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.

Treatment and study plan

[18F] Flutemetamol

Drug

Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.

Other names: AH110690

Primary outcomes

  1. Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid

    Time frame: PET scans performed on patients 90 minutes post Flutemetmol Administration

    The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.

    The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).

Secondary outcomes

  1. Measurement of Amyloid Content in Different Parts of the Brain

    Time frame: PET scans performed on patients 90 minutes post Flutemetmol Administration

    Is the computerized measurement of amyloid content in different parts of the brain.

    The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.

    The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.

    The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Medpace, Inc.
  • i3 Statprobe

Registry information

Official study title

A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 23, 2010
Registry last updated
Jul 2, 2013

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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