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Completed

NCT Number: NCT02120664

Florbetapir Calibration to the Centiloid Scale

This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Heidelberg, Victoria, Australia

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cognitively Normal Subjects
  • Males or females ≥ 21 and ≤ 45 years of age
  • Mini-mental state examination (MMSE) ≥ 29
  • Clinically Diagnosed AD Subject
  • Males or females ≥ 50 years of age
  • Meet clinical criteria for dementia due to probable AD
  • MMSE ≥ 16 and ≤ 26
  • Possible AD Subject
  • Males or females ≥ 50 years of age
  • Meet clinical criteria for dementia due to possible AD
  • MMSE ≥ 16 and ≤ 26
  • MCI Subject
  • Males or females ≥ 60 years of age with cognitive impairment (not dementia)
  • MMSE >24 and <29
  • At Risk Elderly Subject
  • Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age
  • MMSE ≥ 27

Exclusion criteria

  • Have had or currently have a diagnosis of neurodegenerative disorders other than AD
  • Have a current serious or unstable illness that could interfere with completion of the study
  • Subject has a known brain lesion, pathology or traumatic brain injury
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception

Treatment and study plan

florbetapir (18F)

Drug

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

11C-PiB

Drug

Other names: Pittsburgh Compound B

Primary outcomes

  1. Florbetapir SUVr Conversion to Centiloid Units

    Time frame: up to 70 minutes post injection

    Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.

Secondary outcomes

  1. Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid

    Time frame: up to 70 minutes post injection

    Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.

  2. Variability of PET Images in Young Healthy Control Subjects.

    Time frame: up to 70 minutes post injection

    Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2014
Registry last updated
Mar 9, 2017

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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