Trial Outcomes & Findings for Clinical Evaluation of Flortaucipir F 18 (NCT NCT02278367)

Last Updated: 2020-09-10

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

179 participants

Primary outcome timeframe

within 48 hours of drug administration

Results posted on

2020-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Cognitively Impaired Cognitively impaired subjects receiving a flortaucipir PET scan	Cognitively Normal Cognitively normal subjects receiving a flortaucipir PET scan
Overall Study STARTED	69	110
Overall Study COMPLETED	59	110
Overall Study NOT COMPLETED	10	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cognitively Impaired Cognitively impaired subjects receiving a flortaucipir PET scan	Cognitively Normal Cognitively normal subjects receiving a flortaucipir PET scan
Overall Study Physician Decision	5	0
Overall Study Withdrawal by Subject	5	0

Baseline Characteristics

Clinical Evaluation of Flortaucipir F 18

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitively Impaired n=69 Participants Cognitively impaired subjects receiving a flortaucipir PET scan	Cognitively Normal n=110 Participants Cognitively normal subjects receiving a flortaucipir PET scan	Total n=179 Participants Total of all reporting groups
Age, Continuous	72.7 years STANDARD_DEVIATION 7.6 • n=5 Participants	70.4 years STANDARD_DEVIATION 8.18 • n=7 Participants	71.3 years STANDARD_DEVIATION 8.02 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	68 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	42 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants	100 Participants n=7 Participants	169 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	105 Participants n=7 Participants	167 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	110 participants n=7 Participants	179 participants n=5 Participants
MMSE	21 score on a scale STANDARD_DEVIATION 4.35 • n=5 Participants	29.3 score on a scale STANDARD_DEVIATION 1.06 • n=7 Participants	26.1 score on a scale STANDARD_DEVIATION 4.92 • n=5 Participants

PRIMARY outcome

Timeframe: within 48 hours of drug administration

Outcome measures

Outcome measures
Measure	Cognitively Impaired n=69 Participants Cognitively impaired subjects receiving a flortaucipir PET scan	Cognitively Normal n=110 Participants Cognitively normal subjects receiving a flortaucipir PET scan
Number of Participants With Adverse Events Related to Flortaucipir Administration Headache	0 Participants	3 Participants
Number of Participants With Adverse Events Related to Flortaucipir Administration Dysgeusia	0 Participants	3 Participants

PRIMARY outcome

Timeframe: baseline and follow-up scans

Population: Includes only subjects for whom a quantitative image analysis was possible

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.

Outcome measures

Outcome measures
Measure	Cognitively Impaired n=63 Participants Cognitively impaired subjects receiving a flortaucipir PET scan	Cognitively Normal n=107 Participants Cognitively normal subjects receiving a flortaucipir PET scan
Flortaucipir PET Scan SUVr Baseline SUVr	1.3983 standardized uptake value ratio (SUVr) Standard Deviation 0.3641	1.004 standardized uptake value ratio (SUVr) Standard Deviation 0.04871
Flortaucipir PET Scan SUVr Follow-up Scan SUVr	1.4404 standardized uptake value ratio (SUVr) Standard Deviation 0.37426	—

Adverse Events

Cognitively Impaired

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cognitively Normal

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Medical Director

Avid Radiopharmaceuticals, Inc.

Phone: 215-298-0700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Cognitively Impaired n=69 participants at risk Cognitively impaired subjects receiving a flortaucipir PET scan	Cognitively Normal n=110 participants at risk Cognitively normal subjects receiving a flortaucipir PET scan
Nervous system disorders headache	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	4.5% 5/110 • Number of events 5 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Nervous system disorders dysgeusia	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	2.7% 3/110 • Number of events 3 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Nervous system disorders dizziness	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Nervous system disorders paraesthesia	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
General disorders injection site pain	1.4% 1/69 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
General disorders asthenia	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
General disorders feeling abnormal	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
General disorders gait abnormal	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
General disorders injection site coldness	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Investigations blood pressure increased	2.9% 2/69 • Number of events 2 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	1.8% 2/110 • Number of events 2 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Gastrointestinal disorders dry mouth	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	1.8% 2/110 • Number of events 2 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Gastrointestinal disorders nausea	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Cardiac disorders palpitations	1.4% 1/69 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.00% 0/110 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Infections and infestations nasopharyngitis	1.4% 1/69 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.00% 0/110 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Injury, poisoning and procedural complications procedural headache	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Psychiatric disorders insomnia	1.4% 1/69 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.00% 0/110 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Renal and urinary disorders loss of bladder sensation	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.
Skin and subcutaneous tissue disorders hyperhidrosis	0.00% 0/69 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.	0.91% 1/110 • Number of events 1 • AEs were collected at scan visit and for 48 hours after flortaucipir administration. AEs defined as occurring or worsening after injection, within 48 hours, at an imaging visit. AEs occurring after administration, but outside that window were not reported, unless considered attributable to study drug. Note: AE results differ from results reported above because this section reports ALL adverse events, regardless of investigator's designation of relatedness.