This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).

Data analyzed using the E-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline efficacy assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline ADAS-cog11 as a covariate).

This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group. The scores on this scale range from 0 to 78, with higher numbers indicating a better outcome (lower impairment).

Data analyzed using the E-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline efficacy assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline ADCS-ADL23 as a covariate).

This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the placebo group. All laboratory test or vital sign parameter abnormalities deemed clinically significant by the Investigator are to be reported as adverse events.

This secondary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group.

Data analyzed using the MI-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline MRI assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline MRI whole brain volume as a covariate).

This secondary outcome measure (normalized to pons) was assessed in the TRx0237 16 mg/day dose group compared to the control group, and restricted to subjects with Clinical Dementia Rating (CDR) 0.5 at Screening.

Data analyzed using the PI-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline 18F-FDG-PET SUVR assessment; results reported for subjects with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (ANCOVA with fixed effects, including Baseline PET temporal lobe glucose uptake as a covariate).

This secondary outcome measure was assessed in the TRx0237 16mg/day group compared to the control group.

Data analyzed using the MI-MITTv5 Population (all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline MRI assessment); results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline MRI whole temporoparietal lobe volume as a covariate).

This secondary outcome measure was assessed in the TRx0237 8 mg/day group compared to the control group. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).

Note: Estimates for the Control Arm in the primary outcome and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.

Data analyzed using the E-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline efficacy assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline ADAS-cog11 as a covariate).

This secondary outcome measure was assessed in the TRx0237 8 mg/day group compared to the control group. The scores on this scale range from 0 to 78, with higher numbers indicating a better outcome (lower impairment).

Note: Estimates for the Control Arm in the primary outcome and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.

Data analyzed using the E-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline efficacy assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline ADCS-ADL23 as a covariate).

This secondary outcome measure was assessed in the TRx0237 8mg/day dose group compared to the control group, and restricted to subjects with Clinical Dementia Rating (CDR) 0.5 at Screening.

Note: Estimates for the Control Arm in the TRx0237 16 mg/day dose group comparison and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.

Data analyzed using the PI-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline 18F-FDG-PET SUVR assessment; results reported for subjects with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (ANCOVA with fixed effects, including Baseline PET temporal lobe glucose uptake as a covariate).

This secondary outcome measure was assessed in the TRx0237 8 mg/day dose group compared to the control group.

Note: Estimates for the Control Arm in the TRx0237 16 mg/day dose group comparison and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.

Data analyzed using the MI-MITTv5 Population (all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline MRI assessment); results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline MRI whole temporoparietal volume as a covariate).

This secondary outcome measure was assessed for the open-label period of the study comparing subjects originally randomized to placebo to subjects originally randomized to either dose of TRx0237. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).

Note: It was prespecified to combine subjects who received TRx0237 8 mg/day or TRx0237 16 mg/day in the double-blind phase as early starters; thus these are combined for this comparison.

Data analyzed using the ITTv5-OL Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug in the open-label (OL) phase; results reported for subjects in this population with a Baseline-OL value and Week 104 data (52 weeks of OL drug). Change from Baseline-OL to Week 104 (52 weeks) is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline-OL ADAS-cog11 as a covariate).

This secondary outcome measure was assessed in the TRx0237 8 mg/day group compared to the control group over 52 weeks. All laboratory test or vital sign parameter abnormalities deemed clinically significant by the Investigator were to be reported as adverse events.

This secondary outcome measure was assessed for all subjects receiving TRx0237 in the open-label phase of the study (in which subjects had received TRx0237 for up to 104 weeks).

Note: Subjects who received TRx0237 8 mg/day or TRx0237 16 mg/day arms in the double-blind phase are combined for this comparison as all had previously received TRx0237 as compared to those subjects in the control arm who were receiving TRx0237 for the first time in the open-label phase.

A total of 7 subjects had discontinued study drug in the double-blind phase but completed this phase and continued to attend study visits in the open-label (OL) phase off-treatment. As these subjects did not receive TRX0237 16 mg/day in the OL phase, they are not included in the OL-Safety Population (N=449) and thus are not included in these comparisons.