A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
1 other identifier
interventional
24
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2013
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2013
CompletedStudy Start
First participant enrolled
November 13, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2014
CompletedResults Posted
Study results publicly available
September 7, 2020
CompletedSeptember 7, 2020
August 1, 2020
7 months
November 8, 2013
July 16, 2020
August 20, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
80-100 minutes postdose
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
110-130 minutes postdose
Study Arms (3)
Healthy Volunteer Subjects
EXPERIMENTALHealthy males or females 50 years or older with no evidence of cognitive impairment
MCI subjects
EXPERIMENTALSubjects 50 years or older with mild cognitive impairment (MCI)
Probable AD Subjects
EXPERIMENTALSubjects 50 years or older with probable Alzheimer's Disease (AD)
Interventions
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Research Site
Newport Beach, California, 92663, United States
Research Site
New Haven, Connecticut, 06510, United States
Related Publications (1)
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.
PMID: 29284675RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Avid Radiopharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Chief Medical Officer
Avid Radiopharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2013
First Posted
November 25, 2013
Study Start
November 13, 2013
Primary Completion
May 30, 2014
Study Completion
May 30, 2014
Last Updated
September 7, 2020
Results First Posted
September 7, 2020
Record last verified: 2020-08