Trial Outcomes & Findings for Tau Screening Study in Patients With Early Symptomatic AD (NCT NCT03322462)

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 AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

155 participants

Primary outcome timeframe

baseline scan

Results posted on

2020-08-24

Participant Flow

Enrollment occurred between Nov 2017 and Aug 2018. Recruited subjects with clinically diagnosed early AD who were interested in participating in AD therapeutic clinical trial AACG (Eli Lilly and Company; TRAILBLAZER-ALZ; NCT03367403)

Participant milestones

Participant milestones
Measure	Early Symptomatic AD Subjects Early Symptomatic AD subjects in the flortaucipir PET scan arm
Overall Study STARTED	155
Overall Study Flortaucipir PET Scan	155
Overall Study COMPLETED	152
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Early Symptomatic AD Subjects Early Symptomatic AD subjects in the flortaucipir PET scan arm
Overall Study Technical difficulties	2
Overall Study Other	1

Baseline Characteristics

Tau Screening Study in Patients With Early Symptomatic AD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Symptomatic AD Subjects n=155 Participants Early Symptomatic AD subjects in the flortaucipir PET scan arm
Age, Continuous	74.7 years STANDARD_DEVIATION 6.19 • n=39 Participants
Sex: Female, Male Female	76 Participants n=39 Participants
Sex: Female, Male Male	79 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	3 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	15 Participants n=39 Participants
Race (NIH/OMB) White	137 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
MMSE	24.5 units on a scale STANDARD_DEVIATION 2.18 • n=39 Participants

PRIMARY outcome

Timeframe: baseline scan

Population: Includes all subjects who completed the study with valid flortaucipir PET scan (n=152)

Outcome measures

Outcome measures
Measure	Early Symptomatic AD, Eligible for AACG Study n=58 Participants Subjects determined to be eligible for the AACG Study from the flortaucipir PET scan arm.	Early Symptomatic AD, Ineligible for AACG Study n=94 Participants Subjects who were not eligible for the AACG Study from the flortaucipir PET scan arm.	Early Symptomatic AD (Total) n=152 Participants All subjects with early symptomatic AD from the flortaucipir PET scan arm
Flortaucipir Qualitative Results (Visual Reads) τAD++, advanced AD pattern	56 Participants	22 Participants	78 Participants
Flortaucipir Qualitative Results (Visual Reads) τAD+, moderate AD pattern	2 Participants	8 Participants	10 Participants
Flortaucipir Qualitative Results (Visual Reads) τAD-, pattern not consistent with AD	0 Participants	64 Participants	64 Participants

PRIMARY outcome

Timeframe: baseline scan

Population: SUVr was not collected for patients with a τAD- result

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. Eligibility for AACG study was determined from the flortaucipir PET scan quantitation (SUVr; see below) according to protocol-specified criteria that excluded subjects with tau PET signal that was above or below study criteria.

Outcome measures

Outcome measures
Measure	Early Symptomatic AD, Eligible for AACG Study n=58 Participants Subjects determined to be eligible for the AACG Study from the flortaucipir PET scan arm.	Early Symptomatic AD, Ineligible for AACG Study n=30 Participants Subjects who were not eligible for the AACG Study from the flortaucipir PET scan arm.	Early Symptomatic AD (Total) n=88 Participants All subjects with early symptomatic AD from the flortaucipir PET scan arm
Flortaucipir Quantitative Results (SUVr) SUVr all	1.21207 standardized uptake value ratio (SUVr) Standard Deviation 0.119729	1.48576 standardized uptake value ratio (SUVr) Standard Deviation 0.316435	1.30537 standardized uptake value ratio (SUVr) Standard Deviation 0.244527
Flortaucipir Quantitative Results (SUVr) SUVr τAD++ subjects	1.21518 standardized uptake value ratio (SUVr) Standard Deviation 0.120696	1.65880 standardized uptake value ratio (SUVr) Standard Deviation 0.143067	1.34031 standardized uptake value ratio (SUVr) Standard Deviation 0.237395
Flortaucipir Quantitative Results (SUVr) SUVr τAD+ subjects	1.12490 standardized uptake value ratio (SUVr) Standard Deviation 0.012021	1.00991 standardized uptake value ratio (SUVr) Standard Deviation 0.023239	1.03291 standardized uptake value ratio (SUVr) Standard Deviation 0.052789

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=155 participants at risk All subjects with early symptomatic AD from the flortaucipir PET scan arm who received one dose of flortaucipir
Gastrointestinal disorders diarrhoea	1.3% 2/155 • 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