CompletedNCT02278367Updated Sep 10, 2020Results posted

Clinical Evaluation of Flortaucipir F 18

A Phase 2 interventional study of Flortaucipir F18 and Brain PET scan in Alzheimer's Disease, Traumatic Brain Injury and Depression, sponsored by Avid Radiopharmaceuticals. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-10.

Sponsored by Avid Radiopharmaceuticals · Phase 2, Interventional, and Diagnostic

Phase: Phase 2
Study type: Interventional
Enrollment: 179
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.

Conditions studied

Alzheimer's Disease
Traumatic Brain Injury
Depression

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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 179 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

Avid Radiopharmaceuticals is the lead sponsor of 54 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.

Inclusion criteria

Inclusion Criteria:

Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study

Exclusion criteria

Exclusion Criteria:

Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
Have a screening electrocardiogram with a corrected QT interval (QTc) > 450 msec if male or QTc > 470 msec if female
Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
Have a history of relevant severe drug allergy or hypersensitivity
Are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study
Are patients with current clinically significant unstable medical comorbidities
Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study

Study design

Phase: Phase 2
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 179 participants (actual)

Study arms

Experimental
Flortaucipir PET Scans
Drug: Flortaucipir F18 · Procedure: Brain PET scan

Interventions

DrugFlortaucipir F18
IV injection, 370 MBq (10 mCi), up to two doses
Also known as: [F-18]T807, 18F-AV-1451, LY3191748, Tauvid
ProcedureBrain PET scan
positron emission tomography (PET) scan of the brain

What researchers measure

Primary outcomes

Number of Participants With Adverse Events Related to Flortaucipir Administration
Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency \> 1.5% are reported. (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).
Time frame: within 48 hours of drug administration
Flortaucipir PET Scan SUVr
Standard Uptake Value Ratio (SUVr) using a weighted cortical average. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Time frame: baseline and follow-up scans

Results

Posted Sep 10, 2020

Participant flow

Participant flow — Overall Study
Milestone	Cognitively Impaired	Cognitively Normal
Started	69	110
Completed	59	110
Not completed	10	0
Withdrew: Physician decision	5	0
Withdrew: Withdrawal by subject	5	0

Outcome measures

PrimaryNumber of Participants With Adverse Events Related to Flortaucipir Administration

Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency \> 1.5% are reported. (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).

Time frame:: within 48 hours of drug administration
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events Related to Flortaucipir Administration
Participants	Cognitively Impaired	Cognitively Normal
Headache	0	3
Dysgeusia	0	3

PrimaryFlortaucipir PET Scan SUVr

Standard Uptake Value Ratio (SUVr) using a weighted cortical average. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Time frame:: baseline and follow-up scans
Reported as:: Mean · standardized uptake value ratio (SUVr)

Flortaucipir PET Scan SUVr
standardized uptake value ratio (SUVr)	Cognitively Impaired	Cognitively Normal
Baseline SUVr	1.3983 ± 0.3641	1.004 ± 0.04871
Follow-up Scan SUVr	1.4404 ± 0.37426	—

Adverse events

Collected over AEs were collected at scan visit and for 48 hours after flortaucipir administration.. Non-serious events are listed at a 0.5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cognitively Impaired	0/69 (0%)	0/69 (0%)	6/69 (8.7%)
Cognitively Normal	0/110 (0%)	0/110 (0%)	16/110 (14.5%)

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	Cognitively Impaired	Cognitively Normal
headacheNervous system disorders	0/69	5/110
blood pressure increasedInvestigations	2/69	2/110
dysgeusiaNervous system disorders	0/69	3/110
dry mouthGastrointestinal disorders	0/69	2/110
injection site painGeneral disorders	1/69	1/110
palpitationsCardiac disorders	1/69	0/110
nasopharyngitisInfections and infestations	1/69	0/110
insomniaPsychiatric disorders	1/69	0/110
dizzinessNervous system disorders	0/69	1/110
paraesthesiaNervous system disorders	0/69	1/110

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Cognitively Impaired	Cognitively Normal	Total
Mean	72.7 ± 7.6	70.4 ± 8.18	71.3 ± 8.02

Sex: Female, Male
Sex: Female, Male(Participants)	Cognitively Impaired	Cognitively Normal	Total
Female	34	68	102
Male	35	42	77

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cognitively Impaired	Cognitively Normal	Total
Hispanic or Latino	0	10	10
Not Hispanic or Latino	69	100	169
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cognitively Impaired	Cognitively Normal	Total
American Indian or Alaska Native	0	0	0
Asian	1	0	1
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	5	5	10
White	62	105	167
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Cognitively Impaired	Cognitively Normal	Total
United States	69	110	179

MMSE
MMSE(score on a scale)	Cognitively Impaired	Cognitively Normal	Total
Mean	21 ± 4.35	29.3 ± 1.06	26.1 ± 4.92

Study locations

5 sites

Banner Alzheimer's Institute
Phoenix, Arizona 85006, United States
Yale University
New Haven, Connecticut 06510, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada 89106, United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
Center for Vital Longevity at the University of Texas at Dallas
Dallas, Texas 75235, United States

References and documents

Study documents

Study protocol · Sep 5, 2014
Statistical analysis plan · Dec 6, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02278367
Lead sponsor: Avid Radiopharmaceuticals
Responsible party: Sponsor
First posted: Oct 30, 2014
Start date: Dec 2014
Primary completion: Jun 26, 2019
Completion: Jun 26, 2019
Results posted: Sep 10, 2020
Last update: Sep 10, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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