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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Flortaucipir F18
Brain PET scan
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy Volunteer Subjects

MCI subjects

Probable AD Subjects

Arm Description

Healthy males or females 50 years or older with no evidence of cognitive impairment

Subjects 50 years or older with mild cognitive impairment (MCI)

Subjects 50 years or older with probable Alzheimer's Disease (AD)

Outcomes

Primary Outcome Measures

Test-Retest Reproducibility
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
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

Secondary Outcome Measures

Full Information

First Posted
November 8, 2013
Last Updated
August 20, 2020
Sponsor
Avid Radiopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01992380
Brief Title
A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
Official Title
Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 13, 2013 (Actual)
Primary Completion Date
May 30, 2014 (Actual)
Study Completion Date
May 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteer Subjects
Arm Type
Experimental
Arm Description
Healthy males or females 50 years or older with no evidence of cognitive impairment
Arm Title
MCI subjects
Arm Type
Experimental
Arm Description
Subjects 50 years or older with mild cognitive impairment (MCI)
Arm Title
Probable AD Subjects
Arm Type
Experimental
Arm Description
Subjects 50 years or older with probable Alzheimer's Disease (AD)
Intervention Type
Drug
Intervention Name(s)
Flortaucipir F18
Other Intervention Name(s)
[F18]T807, 18F-AV-1451, Tauvid
Intervention Description
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Intervention Type
Procedure
Intervention Name(s)
Brain PET scan
Intervention Description
positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection
Primary Outcome Measure Information:
Title
Test-Retest Reproducibility
Description
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
Time Frame
80-100 minutes postdose
Title
Test-Retest Reproducibility
Description
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
Time Frame
110-130 minutes postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29284675
Citation
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.
Results Reference
result

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

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