ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.

The Full Analysis Set (FAS) is defined as all participants who were randomized. The FAS was the primary analysis set for efficacy data.

The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.

The FAS is defined as all participants who are randomized. The FAS was the primary analysis set for efficacy data.

Proportion of participants with TEAEs leading to discontinuation over the 12-week double blind treatment period and washout. Adverse events (AEs) occurring following start of treatment or increasing in severity were counted as treatment emergent

All participants who received any treatment during double blind period

Proportion (%) of participants with laboratory abnormalities (without regard to baseline abnormalities) of potential clinical concern over the 12-week double blind treatment period.

The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (only at screening or needed: urine drug screen, thyroid panel, Vitamin B12, methylmalonic acid, folate and Hemoglobin A1).

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

Proportion (%) of participants with PR Interval abnormalities meeting categorical criteria over the 12 week double blind treatment period. The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline PR absolute value>=300 msec , a PR increase of >=25% (for participants with a baseline value>=200 msec), or with an increase >=50% (for participants with a baseline value<200 msec) were counted.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

Proportion (%) of participants with QRS Complex abnormalities meeting categorical criteria over the 12 week double blind treatment period. The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline QRS complex absolute value>=100 msec , a QRS complex increase of >=25% (for participants with a baseline value>=100 msec), or with an increase >=50% (for participants with a baseline value<100 msec) were counted.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

Proportion (%) of participants with QTcF Interval abnormalities meeting categorical criteria over the 12-week double blind treatment period. The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.

Participants with a post-baseline QTcF absolute value of 450 - <480, 480 - <500, or >=500 mec, or with a post-baseline QTcF increase of 30 - <60 or >=60 msec were counted.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The BP changes from baseline at Week 6 (Visit 3) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The pulse rate changes from baseline at Week 6 (Visit 3) including supine pulse rate, and standing pulse rate.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The BP changes from baseline at Week 10 (Visit 4) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The pulse rate changes from baseline at Week 10 (Visit 4) including supine pulse rate, and standing pulse rate.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The BP changes from baseline at Week 16/Early Termination (Visit 5) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

The pulse rate changes from baseline at Week 16/Early Termination (Visit 5) including supine pulse rate, and standing pulse rate.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

Proportion (%) of participants with vital signs abnormalities (absolute and change from baseline) meeting categorical criteria over the 12-week double blind treatment period were counted. Vital signs data included blood pressure (BP) and pulse rate.

All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)

Participants in each category of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) mapped from the Columbia-Suicide Severity Rating Scale (C-SSRS) responses were reported.

C-CASA Event Code: <1> Completed suicide; <2> Suicide attempt; <3> Preparatory acts towards imminent suicidal behavior; <4> Suicidal Ideation; <7> Self-injurious behavior, no suicidal intent.

The suicidality assessments were performed at Screening, Week 0 (Visit 1), Week 4 (Visit 2), Week 6, (Visit 3), Week 10 (Visit 4), Week 16 (Visit 5), and Week 18 (Visit 6).

Only participants falling any category of C-CASA events were listed below.

All participants screened and assigned