NCT03322462

Tau Screening Study in Patients With Early Symptomatic AD

Completed Phase 2 Results posted Last updated 24 August 2020

What this trial tests

Phase 2 trial testing Flortaucipir F18 in Alzheimer Disease in 155 participants. Completed in 31 August 2018.

Timeline

21 November 2017

Primary endpoint
31 August 2018

31 August 2018

Quick facts

Lead sponsor	Avid Radiopharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	155
Start date	21 November 2017
Primary completion	31 August 2018
Estimated completion	31 August 2018
Sites	10 locations across Canada, United States

Drugs / interventions tested

• Flortaucipir F18 — full drug profile →
• Brain PET Scan

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Avid Radiopharmaceuticals — full company profile →

Who can join

Adults 60 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Flortaucipir Qualitative Results (Visual Reads) Primary · baseline scan

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.

Group	Value	95% CI
Early Symptomatic AD, Eligible for AACG Study	56
Early Symptomatic AD, Ineligible for AACG Study	22
Early Symptomatic AD (Total)	78
Early Symptomatic AD, Eligible for AACG Study	2
Early Symptomatic AD, Ineligible for AACG Study	8
Early Symptomatic AD (Total)	10
Early Symptomatic AD, Eligible for AACG Study	0
Early Symptomatic AD, Ineligible for AACG Study	64
Early Symptomatic AD (Total)	64

Flortaucipir Quantitative Results (SUVr) Primary · baseline scan

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.

SUVr all

Group	Value	95% CI
Early Symptomatic AD, Eligible for AACG Study	1.21207	± 0.119729
Early Symptomatic AD, Ineligible for AACG Study	1.48576	± 0.316435
Early Symptomatic AD (Total)	1.30537	± 0.244527

SUVr τAD++ subjects

Group	Value	95% CI
Early Symptomatic AD, Eligible for AACG Study	1.21518	± 0.120696
Early Symptomatic AD, Ineligible for AACG Study	1.65880	± 0.143067
Early Symptomatic AD (Total)	1.34031	± 0.237395

SUVr τAD+ subjects

Group	Value	95% CI
Early Symptomatic AD, Eligible for AACG Study	1.12490	± 0.012021
Early Symptomatic AD, Ineligible for AACG Study	1.00991	± 0.023239
Early Symptomatic AD (Total)	1.03291	± 0.052789

Adverse events — posted to ClinicalTrials.gov

Time frame: 48 hours after study drug administration. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Safety Analysis Population

Serious: 0/155 (0%)

Deaths: 0/155

Other adverse events (1 terms — click to expand)

Reaction	System	Safety Analysis Population
diarrhoea	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03322462 adverse events section.

Sponsor's own description

This protocol is designed to serve as a pre-screening study for subjects who are potentially eligible for Alzheimer's Disease (AD) therapeutic trials that require tau imaging for inclusion by means of a flortaucipir F18 Positron Emission Tomography (PET) scan.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.