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

Phase 2

Completed

• Conditions: Apathy in Dementia
• Interventions: Drug: CVL-871 1.0 mg; Drug: CVL-871 3.0 mg; Drug: Placebo

• Registration Number: NCT04958031
• Lead Sponsor: AbbVie

Brief Summary

The purpose of this study is to determine whether CVL-871 is safe and tolerable in patients with Dementia-Related Apathy and if CVL-871 shows changes in clinical measurements of apathy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-08
• Study Start: 2021-06-22
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-12
• Primary Completion: 2025-02-13
• Study Completion: 2025-02-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Meets diagnostic criteria for apathy in neurocognitive disorders
• Clinically significant apathy
• Mild to Moderate Dementia (AD, FTD, VAD, or DLB)

Exclusion Criteria

• Other significant psychiatric disorder(s)
• Other neurological disorders (other than AD, FTD, VAD, or DLB)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CVL-871 1.0 mg	CVL-871 1.0 mg	Participants will receive CVL-871 tablets orally QD up to the maximum dose of 1.0 milligrams (mg) until Day 85 during the treatment period.
CVL-871 3.0 mg	CVL-871 3.0 mg	Participants will receive CVL-871 tablets orally QD up to the maximum dose of 3.0 milligrams (mg) until Day 85 during the treatment period.
Placebo	Placebo	Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period.

Primary Outcome Measures

Name	Time	Method
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)	From first dose of study drug up to Week 16 (follow-up period)	Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE)
Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)	Baseline up to Week 14 (follow up period)	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).
Incidence of clinically significant changes in electrocardiogram (ECG) results	Baseline up to Week 16 or early termination (ET)	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
Incidence in clinically significant changes in vital sign measurements	Baseline up to Week 14 or early termination (ET)	Assessment of clinically significant changes in vital signs including temperature, systolic and diastolic blood pressure, and heart rate.
Incidence of clinically significant changes in physical and neurological examination results	Screening up to Week 16 or early termination (ET)
Incidence of clinically significant changes in clinical laboratory results	Baseline up to Week 14 or early termination (ET)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the Dementia Apathy Interview and Rating (DAIR) score	Baseline up to Week 12 or early termination (ET)	The Dementia Apathy Interview Rating (DAIR) is a 16-item structured interview with the primary caregiver designed to assess illness-related changes in motivation, emotional responsiveness, and engagement. The total apathy score is a sum of all items reflecting change (items for which there is no change are not rated), divided by the number of items completed, with higher scores representing greater average apathy. In addition, the frequency of these behaviors is assessed; higher scores represent more frequent apathy-related behavior.

Trial Locations

Locations (19)

Scottsdale, Arizona; 🇺🇸 Scottsdale, Arizona, United States

Little Rock, Arkansas; 🇺🇸 Little Rock, Arkansas, United States

San Diego, California; 🇺🇸 San Diego, California, United States

Santa Ana, California; 🇺🇸 Santa Ana, California, United States

Delray Beach, Florida; 🇺🇸 Delray Beach, Florida, United States

Miami, Florida; 🇺🇸 Miami, Florida, United States

Orlando, Florida; 🇺🇸 Orlando, Florida, United States

Wellington, Florida; 🇺🇸 Wellington, Florida, United States

Decatur, Georgia; 🇺🇸 Decatur, Georgia, United States

Plymouth, Massachusetts; 🇺🇸 Plymouth, Massachusetts, United States

Staten Island, New York; 🇺🇸 Staten Island, New York, United States

Columbus, Ohio; 🇺🇸 Columbus, Ohio, United States

Abington, Pennsylvania; 🇺🇸 Abington, Pennsylvania, United States

Charleston, South Carolina; 🇺🇸 Charleston, South Carolina, United States

Fairfax, Virginia; 🇺🇸 Fairfax, Virginia, United States

Calgary, Alberta; 🇨🇦 Calgary, Alberta, Canada

Victoria, British Columbia; 🇨🇦 Victoria, British Columbia, Canada

Toronto, Ontario; 🇨🇦 Toronto, Ontario, Canada

New Haven, Connecticut; 🇺🇸 New Haven, Connecticut, United States