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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

Tracking Information
First Submitted Date  ICMJE November 8, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE July 16, 2020
Results First Posted Date  ICMJE September 7, 2020
Last Update Posted Date September 7, 2020
Actual Study Start Date  ICMJE November 13, 2013
Actual Primary Completion Date May 30, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
Test-Retest Reproducibility [ Time Frame: 130 minutes post injection ]
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 cerebellum, will be evaluated using intraclass correlation.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
Official Title  ICMJE Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Healthy Volunteer Subjects
    Healthy males or females 50 years or older with no evidence of cognitive impairment
    Interventions:
    • Drug: Flortaucipir F18
    • Procedure: Brain PET scan
  • Experimental: MCI subjects
    Subjects 50 years or older with mild cognitive impairment (MCI)
    Interventions:
    • Drug: Flortaucipir F18
    • Procedure: Brain PET scan
  • Experimental: Probable AD Subjects
    Subjects 50 years or older with probable Alzheimer's Disease (AD)
    Interventions:
    • Drug: Flortaucipir F18
    • Procedure: Brain PET scan
Publications * Devous MD Sr, Joshi AD, Navitsky M, Southekal S, Pontecorvo MJ, Shen H, Lu M, Shankle WR, Seibyl JP, Marek K, Mintun MA. Test-Retest Reproducibility for the Tau PET Imaging Agent Flortaucipir F 18. J Nucl Med. 2018 Jun;59(6):937-943. doi: 10.2967/jnumed.117.200691. Epub 2017 Dec 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2014)
24
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
30
Actual Study Completion Date  ICMJE May 30, 2014
Actual Primary Completion Date May 30, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01992380
Other Study ID Numbers  ICMJE 18F-AV-1451-A03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avid Radiopharmaceuticals
Study Sponsor  ICMJE Avid Radiopharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
PRS Account Avid Radiopharmaceuticals
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP