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

August 20, 2020 updated by: Avid Radiopharmaceuticals

Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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:
  • 18F-AV-1451
  • Tauvid
  • [F18]T807
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:
  • 18F-AV-1451
  • Tauvid
  • [F18]T807
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:
  • 18F-AV-1451
  • Tauvid
  • [F18]T807
Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
80-100 minutes postdose
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
110-130 minutes postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avid Radiopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 13, 2013

Primary Completion (ACTUAL)

May 30, 2014

Study Completion (ACTUAL)

May 30, 2014

Study Registration Dates

First Submitted

November 8, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-1451-A03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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