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Completed

NCT Number: NCT01992380

A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects

This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.

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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

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Newport Beach, California, 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

  • Healthy Volunteers
  • Male or female subjects ≥ 50 years of age
  • Mini-mental state examination (MMSE) ≥ 29
  • MCI Subjects
  • Male or female subjects ≥ 50 years of age
  • MMSE ≥ 24
  • Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
  • Have a study partner that can report on subject's activities of daily living
  • Probable AD Subjects
  • Male or female subjects ≥ 50 years of age
  • MMSE > 10
  • Meet clinical criteria for probable AD based on the NIA-AA working group's diagnostic guidelines for AD
  • Have a study partner that can report on subject's activities of daily living

Exclusion criteria

  • Current clinically significant psychiatric disease
  • Evidence of structural brain abnormalities
  • Evidence of dementing illness other than AD
  • Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
  • Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
  • History of alcohol or substance abuse or dependence
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  • Have received or participated in a trial with investigational medications in the past 30 days
  • have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.

Treatment and study plan

Flortaucipir F18

Drug

IV injection, 370 MBq (10 mCi), two doses up to four weeks apart

Other names: [F18]T807, 18F-AV-1451, Tauvid

Brain PET scan

Procedure

positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection

Primary outcomes

  1. Test-Retest Reproducibility

    Time frame: 80-100 minutes postdose

    Evaluate test-retest reproducibility of flortaucipir for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects

  2. Test-Retest Reproducibility

    Time frame: 110-130 minutes postdose

    Evaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Sep 7, 2020

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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