Apathy in DementiaPhase 2NCT04958031
A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
A Phase 2 study testing CVL-871 1.0 mg and CVL-871 3.0 mg in people with Apathy in Dementia, run by AbbVie at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Apathy in Dementia
- What is being tested?
- CVL-871 1.0 mg and CVL-871 3.0 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 22 Jun 2021to 12 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for apathy in neurocognitive disorders
- Clinically significant apathy
- Mild to Moderate Dementia (AD, FTD, VAD, or DLB)
Who cannot join
- Other significant psychiatric disorder(s)
- Other neurological disorders (other than AD, FTD, VAD, or DLB)
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States17 sites
Abington, Pennsylvania
Abington, Pennsylvania, 19001
Charleston, South Carolina
Charleston, South Carolina, 29403
Columbus, Ohio
Columbus, Ohio, 43210
Decatur, Georgia
Decatur, Georgia, 30030
Delray Beach, Florida
Delray Beach, Florida, 33445
Fairfax, Virginia
Fairfax, Virginia, 22031
Little Rock, Arkansas
Little Rock, Arkansas, 72114
Miami, Florida
Miami, Florida, 33122
Miami, Florida
Miami, Florida, 33180
New Haven, Connecticut
New Haven, Connecticut, 06510
Orlando, Florida
Orlando, Florida, 32819
Plymouth, Massachusetts
Plymouth, Massachusetts, 02360
San Diego, California
San Diego, California, 92123
Santa Ana, California
Santa Ana, California, 92705
Scottsdale, Arizona
Scottsdale, Arizona, 85258
Staten Island, New York
Staten Island, New York, 10312
Wellington, Florida
Wellington, Florida, 33414
Canada3 sites
Calgary, Alberta
Calgary, Alberta, T2N 4N1
Toronto, Ontario
Toronto, Ontario, M4N 3M5
Victoria, British Columbia
Victoria, British Columbia, V8R 1J8
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
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
- Being tested
- CVL-871 1.0 mg, CVL-871 3.0 mg, Placebo
- Keywords
- Dementia, Apathy
- Medical subject headings
- Dementia, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVL-871 1.0 mgDrug
CVL-871 1.0 mg, oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-7)
CVL-871 3.0 mgDrug
CVL-871 3.0 mg QD oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-21)
PlaceboDrug
Placebo QD, oral (tablet), once per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| CVL-871 1.0 mg | Experimental | 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. Receives: Drug: CVL-871 1.0 mg |
| CVL-871 3.0 mg | Experimental | 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. Receives: Drug: CVL-871 3.0 mg |
| Placebo | Placebo comparator | Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
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.
Measured: 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)
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
Measured: Baseline up to Week 12
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
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.
Measured: Baseline up to Week 12
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
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.
Measured: Baseline up to Week 12
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
The number of participants with clinically significant changes in physical and neurological examination results was documented.
Measured: Baseline to Week 12
Number of Participants With 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).Higher total scores indicate more suicidal ideation and/or suicidal behavior.
Measured: Baseline to Week 12
Secondary outcomes (4)
Change From Baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) Apathy Score
The NPI-C is a participant/caregiver interview covering 14 neuropsychiatric symptom domains (delusions, hallucinations, agitation/aggression, apathy, depression, euphoria, aberrant motor behavior, irritability, disinhibition, anxiety, sleeping, eating, aberrant vocalizations, and dysphoria). The frequency each behavior item are determined on a 5-point scale ranging from 0 (occasionally) to 4 (very frequently). The severity of each behavior item are determined on a 4-point scale ranging from 0 (mild) to 3 (severe). The total NPI-C apathy domain score is the sum of clinician impression severity scores for apathy and ranges from 0-12. Higher scores indicate more severe apathy.
Measured: Baseline to Week 6 and Week 12
Change From Baseline in the Neuropsychiatric Inventory (NPI) Apathy Score
The NPI is a participant/caregiver interview covering 12 neuropsychiatric symptom domains (delusions, hallucinations, agitation/aggression, apathy, depression, euphoria, aberrant motor behavior, irritability, disinhibition, anxiety, sleeping, and eating). The frequency each behavior item are determined on a 5-point scale ranging from 0 (occasionally) to 4 (very frequently). The severity of each behavior item are determined on a 4-point scale ranging from 0 (mild) to 3 (severe). The NPI apathy domain score is the product of frequency score × severity score reported by the caregiver and ranges from 0-12. Higher scores indicate more severe apathy.
Measured: Baseline to Week 6 and Week 12
Change From Baseline in the Dementia Apathy Interview and Rating (DAIR) Score
The DAIR is a clinician-rated, 16-item structured interview that assess illness-related changes in motivation, emotional responsiveness, and engagement. Apathy item scores range from 0 (never) to 3 (almost always). For questions 1, 9, 11, 12, 13, and 14, rescaled score = original score, and for questions 2 - 8, 10, 15, and 16, rescaled score = 3 - original score. Items are counted for the total score only if the behavior represents a change toward apathy from pre-illness behavior. Total scores can range from 0 to 36, with higher scores indicating more severe apathy.
Measured: Baseline to Week 6 and Week 12
Change From Baseline in the Apathy Evaluation Scale-Clinician (AES-C) Score
The AES-C is a clinician-rated 18-item rating scale measures apathy severity in participants. each rated on a 4-point Likert scale ranging from 0 (not at all true) to 3 (very true), with total scores ranging from 0 to 54. Higher scores indicate greater apathy severity.
Measured: Baseline to Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start22 Jun 2021
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Why it stopped: Sponsor Decision - Not Safety Related
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Apathy in DementiaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958031
- Sponsor's protocol ID
- CVL-871-2001
- Other IDs
- IND 150,086
- Status last verified
- Jan 2026
- First submitted
- 8 Jun 2021
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
- ClinicalTrials.gov ID
- NCT04958031
- Acronym / sponsor ID
- CVL-871-2001
- Conditions
- Apathy in Dementia
- Keywords
- Dementia, Apathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision - Not Safety Related
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| CVL-871 1.0 mg | Experimental | Drug: CVL-871 1.0 mgParticipants 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 | Experimental | Drug: CVL-871 3.0 mgParticipants 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 comparator | Drug: PlaceboParticipants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets diagnostic criteria for apathy in neurocognitive disorders
- Clinically significant apathy
- Mild to Moderate Dementia (AD, FTD, VAD, or DLB)
Key exclusion criteria (2 listed)
- Other significant psychiatric disorder(s)
- Other neurological disorders (other than AD, FTD, VAD, or DLB)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVL-871 1.0 mgCVL-871 1.0 mg, oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-7) | Drug | CVL-871 1.0 mg |
| CVL-871 3.0 mgCVL-871 3.0 mg QD oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-21) | Drug | CVL-871 3.0 mg |
| PlaceboPlacebo QD, oral (tablet), once per day for 12 weeks | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Change From Baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) Apathy Score
Time frame: Baseline to Week 6 and Week 12
Change From Baseline in the Neuropsychiatric Inventory (NPI) Apathy Score
Time frame: Baseline to Week 6 and Week 12
Change From Baseline in the Dementia Apathy Interview and Rating (DAIR) Score
Time frame: Baseline to Week 6 and Week 12
Change From Baseline in the Apathy Evaluation Scale-Clinician (AES-C) Score
Time frame: Baseline to Week 6 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVL-871 1.0 mg and CVL-871 3.0 mg in people with Apathy in Dementia, run by AbbVie at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: From first dose of study drug until 4 weeks following last dose of study drug (up to 16 weeks).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.