Trial Outcomes & Findings for Flortaucipir 18F PET Imaging in BIOCARD Study (NCT NCT03052972)

Last Updated: 2020-09-25

Results Overview

Subject scans were visually evaluated by an expert reader into three groups. Advanced Alzheimer's disease (AD) scan pattern = In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the posterolateral temporal (PLT), parietal, or occipital region(s). Moderate AD scan pattern = In either hemisphere, increased neocortical activity limited to the PLT or occipital region(s). Not AD scan pattern = No increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

23 participants

Primary outcome timeframe

Baseline scan

Results posted on

2020-09-25

Participant Flow

Enrollment took place between Mar 2017 and Aug 2018 from the Biomarkers of Cognitive Decline Among Normal Individuals (BIOCARD) study

Participant milestones

Participant milestones
Measure	Amyloid Positive Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan	Amyloid Negative Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan
Overall Study STARTED	18	5
Overall Study COMPLETED	18	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flortaucipir 18F PET Imaging in BIOCARD Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Amyloid Positive n=18 Participants Clinically normal amyloid positive subjects from BIOCARD study	Amyloid Negative n=5 Participants Clinically normal amyloid negative subjects from BIOCARD study	Total n=23 Participants Total of all reporting groups
Age, Continuous	72.1 years STANDARD_DEVIATION 5.69 • n=5 Participants	66.8 years STANDARD_DEVIATION 7.53 • n=7 Participants	70.9 years STANDARD_DEVIATION 6.35 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	4 Participants n=7 Participants	21 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	5 Participants n=7 Participants	23 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	18 participants n=5 Participants	5 participants n=7 Participants	23 participants n=5 Participants
MMSE	29.3 units on a scale STANDARD_DEVIATION 1.02 • n=5 Participants	29.2 units on a scale STANDARD_DEVIATION 1.30 • n=7 Participants	29.3 units on a scale STANDARD_DEVIATION 1.05 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline scan

Population: Subjects with visually evaluable PET scans (n=22). One scan was considered unevaluable by the expert reader.

Outcome measures

Outcome measures
Measure	Amyloid Positive n=17 Participants Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan	Amyloid Negative n=5 Participants Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan	Total All subjects from BIOCARD study receiving a flortaucipir PET scan
Qualitative Evaluation of Scan Results Moderate AD Scan Pattern (τAD+)	0 Participants	0 Participants	—
Qualitative Evaluation of Scan Results Not AD Scan Pattern (τAD-)	6 Participants	5 Participants	—
Qualitative Evaluation of Scan Results Advanced AD Scan Pattern (τAD++)	11 Participants	0 Participants	—

PRIMARY outcome

Timeframe: 75 minutes post dose administration

Standard Uptake Value Ratio (SUVr) by amyloid status 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	Amyloid Positive n=18 Participants Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan	Amyloid Negative n=5 Participants Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan	Total n=23 Participants All subjects from BIOCARD study receiving a flortaucipir PET scan
Quantitative Evaluation of Scan Results	1.0414 standardized uptake value ratio (SUVr) Standard Deviation 0.04165	1.0219 standardized uptake value ratio (SUVr) Standard Deviation 0.02057	1.0371 standardized uptake value ratio (SUVr) Standard Deviation 0.03854

Adverse Events

Amyloid Positive

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Amyloid Negative

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Amyloid Positive n=18 participants at risk Clinically normal amyloid positive subjects from BIOCARD study receiving a flortaucipir PET scan	Amyloid Negative n=5 participants at risk Clinically normal amyloid negative subjects from BIOCARD study receiving a flortaucipir PET scan
Gastrointestinal disorders Abdominal pain upper	5.6% 1/18 • Number of events 1 • AEs were collected at scan visits and for 48 hours after flortaucipir administration. Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.	0.00% 0/5 • AEs were collected at scan visits and for 48 hours after flortaucipir administration. Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • Number of events 1 • AEs were collected at scan visits and for 48 hours after flortaucipir administration. Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.	0.00% 0/5 • AEs were collected at scan visits and for 48 hours after flortaucipir administration. Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.
Nervous system disorders Headache	5.6% 1/18 • Number of events 1 • AEs were collected at scan visits and for 48 hours after flortaucipir administration. Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.	0.00% 0/5 • AEs were collected at scan visits and for 48 hours after flortaucipir administration. Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to study drug.

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