A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy

Number of Participants With Adverse Events

时间窗: From first dose of study drug until 4 weeks following last dose of study drug (up to 16 weeks).

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)

时间窗: Baseline up to Week 12

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

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

时间窗: Baseline up to Week 12

Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes. Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (eg, ECG, radiological scans, vital signs measurements), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the investigator.

Number of Participants With Clinically Significant Changes in Vital Sign Measurements

时间窗: Baseline up to Week 12

Vital signs measured include systolic and diastolic blood pressures, heart rate, and body temperature. Duplicate blood pressure and heart rate measurements were obtained sitting/supine (after 5 minutes of rest) followed by a single standing measurement (after 2 minutes of rising from sitting/supine position). The duplicate values (sitting/supine) were individually recorded, and the values were averaged by the sponsor for the time point assessment. Participants' body weights were also measured and recorded.

Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

时间窗: Baseline to Week 12

The number of participants with clinically significant changes in physical and neurological examination results was documented.

Number of Participants With Clinically Significant Findings in Suicidality Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)

时间窗: Baseline to Week 12

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).Higher total scores indicate more suicidal ideation and/or suicidal behavior.