TerminatedPhase 2

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

Stopped: Sponsor Decision - Not Safety Related

United States, Canada41 participantsStarted 2021-06-22

Plain-language 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.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Adverse Events

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

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

Timeframe: Baseline up to Week 12

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Timeframe: Baseline up to Week 12

Number of Participants With Clinically Significant Changes in Vital Sign Measurements

Timeframe: Baseline up to Week 12

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

Timeframe: Baseline to Week 12

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

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT04958031

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-12

Results submitted2026-01-27

View on ClinicalTrials.gov More Apathy in Dementia trials

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Adverse Events

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

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

Timeframe: Baseline up to Week 12

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Timeframe: Baseline up to Week 12

Number of Participants With Clinically Significant Changes in Vital Sign Measurements

Timeframe: Baseline up to Week 12

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

Timeframe: Baseline to Week 12

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

Timeframe: Baseline to Week 12