NCT04958031

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Apathy in Dementia

Interventions

Type	Name	Description
DRUG	CVL-871 1.0 mg	CVL-871 1.0 mg, oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-7)
DRUG	CVL-871 3.0 mg	CVL-871 3.0 mg QD oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-21)
DRUG	Placebo	Placebo QD, oral (tablet), once per day for 12 weeks

Timeline

• Start date: 2021-06-22
• Primary completion: 2025-02-12
• Completion: 2025-02-12
• First posted: 2021-07-12
• Last updated: 2026-03-11
• Results posted: 2026-03-11

Locations

20 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study