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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992380
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Flortaucipir F18 Procedure: Brain PET scan Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
Actual Study Start Date : November 13, 2013
Actual Primary Completion Date : May 30, 2014
Actual Study Completion Date : May 30, 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy Volunteer Subjects
Healthy males or females 50 years or older with no evidence of cognitive impairment
 Drug: Flortaucipir F18
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Other Names:
  • [F18]T807
  • 18F-AV-1451
  • Tauvid

Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection
Experimental: MCI subjects
Subjects 50 years or older with mild cognitive impairment (MCI)
 Drug: Flortaucipir F18
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Other Names:
  • [F18]T807
  • 18F-AV-1451
  • Tauvid

Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection
Experimental: Probable AD Subjects
Subjects 50 years or older with probable Alzheimer's Disease (AD)
 Drug: Flortaucipir F18
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Other Names:
  • [F18]T807
  • 18F-AV-1451
  • Tauvid

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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992380


Locations
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United States, California
Research Site
Newport Beach, California, United States, 92663
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
More Information
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Publications of Results:

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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01992380    
Other Study ID Numbers: 18F-AV-1451-A03
First Posted: November 25, 2013    Key Record Dates
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders