A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy

Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE)

Time frame: From first dose of study drug up to Week 16 (follow-up period)

Incidence of clinically significant changes in electrocardiogram (ECG) results

Assessment of clinically significant changes in QT intervals measured by 12-lead ECG recording after the participant has been supine and at rest for at least 5 minutes

Time frame: Baseline up to Week 16 or early termination (ET)

Incidence of clinically significant changes in clinical laboratory results

Time frame: Baseline up to Week 14 or early termination (ET)

Incidence in clinically significant changes in vital sign measurements

Assessment of clinically significant changes in vital signs including temperature, systolic and diastolic blood pressure, and heart rate.

Time frame: Baseline up to Week 14 or early termination (ET)

Incidence of clinically significant changes in physical and neurological examination results

Time frame: Screening up to Week 16 or early termination (ET)

Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)

The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).

Time frame: Baseline up to Week 14 (follow up period)