Trial Outcomes & Findings for Tau Screening Study in Subjects With Early Symptomatic AD (NCT NCT03467477)

Last Updated: 2020-08-24

Results Overview

Flortaucipir PET scans were rated visually by an expert reader as follows: Not consistent with an AD pattern (τAD-), Moderate AD pattern (τAD+), or Advanced AD pattern and likely to progress (τAD++). Eligibility for future studies was determined from the flortaucipir PET scan according to protocol-specified criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

161 participants

Primary outcome timeframe

baseline scan

Results posted on

2020-08-24

Participant Flow

Enrollment occurred between Mar 2018 and Nov 2018. Recruited subjects with clinically diagnosed early AD who were interested in participating in AD therapeutic clinical trials being conducted by Eli Lilly and Company.

Participant milestones

Participant milestones
Measure	Early Symptomatic AD Subjects Early Symptomatic AD subjects in the flortaucipir PET scan arm
Overall Study STARTED	161
Overall Study COMPLETED	161
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tau Screening Study in Subjects With Early Symptomatic AD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Symptomatic AD Subjects n=161 Participants Early Symptomatic AD subjects in the flortaucipir PET scan arm
Age, Continuous	75.0 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	154 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
MMSE	25.0 units on a scale STANDARD_DEVIATION 2.51 • n=5 Participants

PRIMARY outcome

Timeframe: baseline scan

Outcome measures

Outcome measures
Measure	Early Symptomatic AD, Eligible for Future Trials n=55 Participants Subjects determined to be eligible for future studies from the flortaucipir PET scan arm.	Early Symptomatic AD, Ineligible for Future Trials n=105 Participants Subjects who were not eligible for future studies from the flortaucipir PET scan arm.	Early Symptomatic AD, Not Evaluable n=1 Participants Subjects determined to be not eligible for future studies from the flortaucipir PET scan arm due to unevaluable PET scan for quantitation	Early Symptomatic AD (Total) n=161 Participants All subjects with early symptomatic AD from the flortaucipir PET scan arm
Flortaucipir Qualitative Results (Visual Reads) τAD++, advanced AD pattern	51 Participants	13 Participants	1 Participants	65 Participants
Flortaucipir Qualitative Results (Visual Reads) τAD+, moderate AD pattern	4 Participants	10 Participants	0 Participants	14 Participants
Flortaucipir Qualitative Results (Visual Reads) τAD-, pattern not consistent with AD	0 Participants	82 Participants	0 Participants	82 Participants

PRIMARY outcome

Timeframe: baseline scan

Population: SUVr was not collected for patients with a τAD- result (n=82) and one subject had an unevaluable flortaucipir scan for quantitation. Therefore, analysis population n=78.

Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain. Visual read categories as described for previous measure.

Outcome measures

Outcome measures
Measure	Early Symptomatic AD, Eligible for Future Trials n=55 Participants Subjects determined to be eligible for future studies from the flortaucipir PET scan arm.	Early Symptomatic AD, Ineligible for Future Trials n=23 Participants Subjects who were not eligible for future studies from the flortaucipir PET scan arm.	Early Symptomatic AD, Not Evaluable n=1 Participants Subjects determined to be not eligible for future studies from the flortaucipir PET scan arm due to unevaluable PET scan for quantitation	Early Symptomatic AD (Total) n=78 Participants All subjects with early symptomatic AD from the flortaucipir PET scan arm
Flortaucipir Quantitative Results (SUVr) SUVr all subjects	1.24766 standardized uptake value ratio (SUVr) Standard Deviation 0.122786	1.38020 standardized uptake value ratio (SUVr) Standard Deviation 0.343791	—	1.28674 standardized uptake value ratio (SUVr) Standard Deviation 0.219185
Flortaucipir Quantitative Results (SUVr) SUVr τAD++ subjects	1.25687 standardized uptake value ratio (SUVr) Standard Deviation 0.122501	1.64935 standardized uptake value ratio (SUVr) Standard Deviation 0.187100	—	1.33659 standardized uptake value ratio (SUVr) Standard Deviation 0.209539
Flortaucipir Quantitative Results (SUVr) SUVr τAD+ subjects	1.13025 standardized uptake value ratio (SUVr) Standard Deviation 0.038043	1.03031 standardized uptake value ratio (SUVr) Standard Deviation 0.039727	—	1.05886 standardized uptake value ratio (SUVr) Standard Deviation 0.060181

Adverse Events

Safety Analysis Population

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Safety Analysis Population n=161 participants at risk All subjects with early symptomatic AD from the flortaucipir PET scan arm who received one dose of flortaucipir
Psychiatric disorders claustrophobia	1.2% 2/161 • Number of events 2 • 48 hours after study drug administration Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. 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