Trial · NCT04958031

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

NCT04958031, Phase 2, Terminated, AbbVie; results first posted 2026-03-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy. Trials, record NCT04958031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04958031

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
NCT number: NCT04958031
Status: Terminated
Phases: Phase 2
Enrollment: 41 participants, actual
Lead sponsor: AbbVie
Conditions: Apathy in Dementia
Interventions: CVL-871 1.0 mg, CVL-871 3.0 mg, Placebo
First posted: 2021-07-12
Last updated: 2026-03-11
Results first posted: 2026-03-11

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events	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.
Primary	Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)	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
Primary	Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments	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.
Primary	Number of Participants With Clinically Significant Changes in Vital Sign Measurements	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.
Primary	Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results	Baseline to Week 12	The number of participants with clinically significant changes in physical and neurological examination results was documented.
Primary	Number of Participants With Clinically Significant Findings in Suicidality Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)	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.
Secondary	Change From Baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) Apathy Score	Baseline to Week 6 and Week 12	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.
Secondary	Change From Baseline in the Neuropsychiatric Inventory (NPI) Apathy Score	Baseline to Week 6 and Week 12	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.
Secondary	Change From Baseline in the Dementia Apathy Interview and Rating (DAIR) Score	Baseline to Week 6 and Week 12	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.
Secondary	Change From Baseline in the Apathy Evaluation Scale-Clinician (AES-C) Score	Baseline to Week 6 and Week 12	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.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events	From first dose of study drug until 4 weeks following last dose of study drug (up to 16 weeks).	Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.	participants	NUMBER
PRIMARY	Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)	Baseline up to Week 12	Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments	Baseline up to Week 12	Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Changes in Vital Sign Measurements	Baseline up to Week 12	Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results	Baseline to Week 12	Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Findings in Suicidality Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)	Baseline to Week 12	Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) Apathy Score	Baseline to Week 6 and Week 12	Modified ITT (mITT): A subset of ITT with randomized participants who tolerate dose increases to at least Step 4 on Day 21 during titration and have at least 1 post-baseline assessment of the NPI-C apathy subscale score.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Neuropsychiatric Inventory (NPI) Apathy Score	Baseline to Week 6 and Week 12	Modified ITT (mITT): A subset of ITT with randomized participants who tolerate dose increases to at least Step 4 on Day 21 during titration and have at least 1 post-baseline assessment of the NPI-C apathy subscale score.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Dementia Apathy Interview and Rating (DAIR) Score	Baseline to Week 6 and Week 12	Modified ITT (mITT): A subset of ITT with randomized participants who tolerate dose increases to at least Step 4 on Day 21 during titration and have at least 1 post-baseline assessment of the NPI-C apathy subscale score.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Apathy Evaluation Scale-Clinician (AES-C) Score	Baseline to Week 6 and Week 12	Modified ITT (mITT): A subset of ITT with randomized participants who tolerate dose increases to at least Step 4 on Day 21 during titration and have at least 1 post-baseline assessment of the NPI-C apathy subscale score.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group120

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events	Placebo	Any TEAE	5	participants
Number of Participants With Adverse Events	CVL-871 1.0 mg	Any TEAE	9	participants
Number of Participants With Adverse Events	CVL-871 3.0 mg	Any TEAE	5	participants
Number of Participants With Adverse Events	Placebo	TESAE	2	participants
Number of Participants With Adverse Events	CVL-871 1.0 mg	TESAE	2	participants
Number of Participants With Adverse Events	CVL-871 3.0 mg	TESAE	0	participants
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)	Placebo	QTcF value > 450 =< 480 msec	3	Participants
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)	CVL-871 1.0 mg	QTcF value > 450 =< 480 msec	0	Participants
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)	CVL-871 3.0 mg	QTcF value > 450 =< 480 msec	2	Participants
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)	Placebo	QTcF value > 480 =< 500 msec	0	Participants

1 to 10 of 120Source ClinicalTrials.gov

See all 120 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	15
Overall Study	STARTED	CVL-871 1.0 mg	14
Overall Study	STARTED	CVL-871 3.0 mg	12
Overall Study	COMPLETED	Placebo	14
Overall Study	COMPLETED	CVL-871 1.0 mg	12
Overall Study	COMPLETED	CVL-871 3.0 mg	6
Overall Study	NOT COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	CVL-871 1.0 mg	2
Overall Study	NOT COMPLETED	CVL-871 3.0 mg	6

Source ClinicalTrials.gov

Adverse events129

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	Placebo	0	15	0
other	ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	CVL-871 1.0 mg	1	14	1
other	ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	CVL-871 3.0 mg	0	12	0
other	BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	Placebo	1	15	1
other	BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	CVL-871 1.0 mg	0	14	0
other	BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	CVL-871 3.0 mg	0	12	0
other	ABDOMINAL DISCOMFORT	Gastrointestinal disorders	Placebo	0	15	0
other	ABDOMINAL DISCOMFORT	Gastrointestinal disorders	CVL-871 1.0 mg	1	14	1
other	ABDOMINAL DISCOMFORT	Gastrointestinal disorders	CVL-871 3.0 mg	1	12	1
other	ABDOMINAL PAIN	Gastrointestinal disorders	Placebo	1	15	1

1 to 10 of 129Source ClinicalTrials.gov

See all 129 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	15
Total, all-cause mortality	CVL-871 1.0 mg	0	14
Total, all-cause mortality	CVL-871 3.0 mg	0	12
Total, other adverse events	Placebo	5	15
Total, other adverse events	CVL-871 1.0 mg	8	14
Total, other adverse events	CVL-871 3.0 mg	5	12
Total, serious adverse events	Placebo	2	15
Total, serious adverse events	CVL-871 1.0 mg	2	14
Total, serious adverse events	CVL-871 3.0 mg	0	12

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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