Adults 50 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.
Maximum Plasma Concentration (Cmax)Primary· Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Blood draws will be done to evaluate levels of PTI-125 in the plasma using non-compartmental methods in WinNonlin.
Day 1 Cmax
Group
Value
95% CI
PTI-125
1020
± 442
Day 28 Cmax
Group
Value
95% CI
PTI-125
1100
± 417
Time to Maximum Plasma Concentration (Tmax)Primary· Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Levels of PTI-125 will be assessed to determine how long it takes to reach the Cmax
Day 1 Tmax
Group
Value
95% CI
PTI-125
2.00
1.00 – 3.00
Day 28 Tmax
Group
Value
95% CI
PTI-125
2.06
1.00 – 5.93
Last Quantifiable Plasma Concentration (Clast)Primary· Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Levels of PTI-125 will be assessed to determine the last time point where PTI-125 can be detected.
Day 1 Clast
Group
Value
95% CI
PTI-125
176
± 112
Day 28 Clast
Group
Value
95% CI
PTI-125
238
± 168
Time to Last Quantifiable Plasma Concentration (Tlast)Primary· Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Levels of PTI-125 will be assessed to determine the elapsed time to where PTI-125 can last be detected in the plasma.
Day 1 Tlast
Group
Value
95% CI
PTI-125
12.0
± 0.0150
Day 28 Tlast
Group
Value
95% CI
PTI-125
12.0
± 0.0285
Area Under the Curve (AUClast)Primary· Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
AUC for PTI-125 plasma concentration from time zero to the last quantifiable plasma concentration.
Day 1 AUClast
Group
Value
95% CI
PTI-125
5320
± 2230
Day 28 AUClast
Group
Value
95% CI
PTI-125
6700
± 3240
Plasma Half-life (T1/2)Primary· Study Day 1 and Day 28 at 20, 40, and 60 min and at 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 h post-dose
Assessment of the half-life in plasma of PTI-125
Day 1 T1/2
Group
Value
95% CI
PTI-125
4.51
± 2.43
Day 28 T1/2
Group
Value
95% CI
PTI-125
4.35
± 1.39
SavaDx (Biomarker)Secondary· Study Day 1 and Day 28
Blood samples will be tested for the complementary diagnostic/biomarker for Alzheimer's disease.
Group
Value
95% CI
PTI-125
-39.8
± 0.19
CSF BiomarkersSecondary· Change from Baseline to Day 28
A cerebrospinal fluid sample collection will be performed for Aβ42, tau, YKL40 and other potential CSF biomarkers
Total tau
Group
Value
95% CI
PTI-125
-19.8
± 0.04
Abeta42
Group
Value
95% CI
PTI-125
4.3
± 0.05
p-tau181
Group
Value
95% CI
PTI-125
-34.4
± 0.05
Neurogranin
Group
Value
95% CI
PTI-125
-32
± 0.02
Neurofilament light chain
Group
Value
95% CI
PTI-125
-22
± 0.02
YKL-40
Group
Value
95% CI
PTI-125
-9
± 0.01
IL-6
Group
Value
95% CI
PTI-125
-14
± 0.01
IL-1 beta
Group
Value
95% CI
PTI-125
-11
± 0.01
Adverse events — posted to ClinicalTrials.gov
Time frame: Within the 28-day treatment period..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pain Therapeutics
Last refreshed: 7 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03748706.