TerminatedPhase 2Results posted

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

Lead sponsor

AbbVie

Asset

CVL-871

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, Frontotemporal dementia, Lewy body dementia, Vascular cognitive impairment / dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoints

•Adverse Events•Clinically Significant Changes in Electrocardiogram (ECGs)•Clinically Significant Changes in Clinical Laboratory Assessments

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCVL-871-2001

Secondary IDIND 150,086IND

NCT IDNCT04958031

Timeline

Milestones

Study start2021-06-22actual

Study first posted2021-07-12actual

Primary completion2025-02-12actual

Study completion2025-02-12actual

Last update posted2026-03-11actual

Results first posted2026-03-11actual

Assets

Drug assets

CVL-871

Study populations

Who this study enrolls

Alzheimer’s diseaseFrontotemporal dementiaLewy body dementiaVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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)

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Safety / tolerability / PK

Other (unclassified)

Behavior / neuropsychiatric

10 endpoints

Primary/protocol endpoint

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

event count, event

Primary/registry result

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

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboSuicidal Ideationn=15 Participants	1	-
Suicidal Behaviorn=15 Participants	0	-
Suicidal Ideation Or Behaviorn=15 Participants	1	-
Self-Injurious Behavior Without Suicidal Intentn=15 Participants	0	-
CVL-871 1.0 mgSuicidal Ideationn=14 Participants	0	-
Suicidal Behaviorn=14 Participants	0	-
Suicidal Ideation Or Behaviorn=14 Participants	0	-
Self-Injurious Behavior Without Suicidal Intentn=14 Participants	0	-
CVL-871 3.0 mgSuicidal Ideationn=12 Participants	0	-
Suicidal Behaviorn=12 Participants	0	-
Suicidal Ideation Or Behaviorn=12 Participants	0	-
Self-Injurious Behavior Without Suicidal Intentn=12 Participants	0	-

Secondary/protocol endpoint

Change From Baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) Apathy Score

Time frame:Baseline to Week 6 and Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Neuropsychiatric Inventory (NPI) Apathy Score

Time frame:Baseline to Week 6 and Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Dementia Apathy Interview and Rating (DAIR) Score

Time frame:Baseline to Week 6 and Week 12

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Apathy Evaluation Scale-Clinician (AES-C) Score

Time frame:Baseline to Week 6 and Week 12

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Neuropsychiatric Inventory - Clinician (NPI-C) Apathy Score

Time frame:Baseline to Week 6 and Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboWeek 6n=15 Participants	-1.5	1.67
Week 12n=14 Participants	-4.6	1.68
CVL-871 1.0 mgWeek 6n=11 Participants	-2.7	2.05
Week 12n=12 Participants	-3.2	1.99
CVL-871 3.0 mgWeek 6n=8 Participants	0.5	2.44
Week 12n=6 Participants	-4.5	2.56

LS Mean of Difference-1.180% CI-4.6 - 2.3p0.663Mixed-Model Repeated Measurement

Week 6

LS Mean of Difference2.080% CI-1.7 - 5.7p0.478Mixed-Model Repeated Measurement

Week 6

LS Mean of Difference1.480% CI-1.9 - 4.8p0.578Mixed-Model Repeated Measurement

Week 12

LS Mean of Difference0.180% CI-3.7 - 4.0p0.963Mixed-Model Repeated Measurement

Week 12

Secondary/registry result

Change From Baseline in the Neuropsychiatric Inventory (NPI) Apathy Score

Time frame:Baseline to Week 6 and Week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboWeek 6n=13 Participants	-2.0	0.68
Week 12n=12 Participants	-0.9	0.73
CVL-871 1.0 mgWeek 6n=11 Participants	0.2	0.76
Week 12n=9 Participants	2.0	0.88
CVL-871 3.0 mgWeek 6n=8 Participants	-1.2	0.88
Week 12n=5 Participants	-2.5	1.13

LS Mean of Difference2.280% CI0.9 - 3.6p0.037Mixed-Model Repeated Measurement

Week 6

LS Mean of Difference0.880% CI-0.6 - 2.2p0.455Mixed-Model Repeated Measurement

Week 6

LS Mean of Difference2.980% CI1.4 - 4.4p0.019Mixed-Model Repeated Measurement

Week 12

LS Mean of Difference-1.680% CI-3.3 - 0.2p0.251Mixed-Model Repeated Measurement

Week 12

Secondary/registry result

Change From Baseline in the Dementia Apathy Interview and Rating (DAIR) Score

Time frame:Baseline to Week 6 and Week 12

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboWeek 6n=14 Participants	0.064	0.1038
Week 12n=13 Participants	-0.151	0.1566
CVL-871 1.0 mgWeek 6n=12 Participants	-0.165	0.1172
Week 12n=12 Participants	-0.152	0.1672
CVL-871 3.0 mgWeek 6n=8 Participants	-0.086	0.1443
Week 12n=6 Participants	-0.104	0.2309

LS Mean of Difference-0.22980% CI-0.430 - -0.027p0.147Mixed-Model Repeated Measurement

Week 6

LS Mean of Difference-0.15080% CI-0.375 - 0.074p0.388Mixed-Model Repeated Measurement

Week 6

LS Mean of Difference-0.00180% CI-0.300 - 0.298p0.996Mixed-Model Repeated Measurement

Week 12

LS Mean of Difference0.04880% CI-0.313 - 0.409p0.864Mixed-Model Repeated Measurement

Week 12

Secondary/registry result

Change From Baseline in the Apathy Evaluation Scale-Clinician (AES-C) Score

Time frame:Baseline to Week 6 and Week 12

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
PlaceboWeek 6n=14 Participants	-0.9	1.99
Week 12n=13 Participants	-4.0	2.55
CVL-871 1.0 mgWeek 6n=11 Participants	-2.1	2.27
Week 12n=12 Participants	-3.0	2.76
CVL-871 3.0 mgWeek 6n=8 Participants	-1.1	2.80
Week 12n=6 Participants	2.5	3.74

LS Mean of Difference-1.280% CI-5.0 - 2.6p0.687Mixed-Model Repeated Measurement

Week 6

LS Mean of Difference-0.280% CI-4.5 - 4.1p0.954Mixed-Model Repeated Measurement

Week 6

LS Mean of Difference1.080% CI-3.9 - 5.8p0.790Mixed-Model Repeated Measurement

Week 12

LS Mean of Difference6.580% CI0.6 - 12.3p0.156Mixed-Model Repeated Measurement

Week 12

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

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).

event count, event

Primary/protocol endpoint

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

Time frame:Baseline up to Week 12

event count, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Time frame:Baseline up to Week 12

event count, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Changes in Vital Sign Measurements

Time frame:Baseline up to Week 12

event count, event

Primary/registry result

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).

event count, event

Posted result

Group	Value (number), participants	Reported bounds
PlaceboAny TEAEn=15 Participants	5	-
TESAEn=15 Participants	2	-
CVL-871 1.0 mgAny TEAEn=14 Participants	9	-
TESAEn=14 Participants	2	-
CVL-871 3.0 mgAny TEAEn=12 Participants	5	-
TESAEn=12 Participants	0	-

Primary/registry result

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

Time frame:Baseline up to Week 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboQTcF value > 450 =< 480 msecn=15 Participants	3	-
QTcF value > 480 =< 500 msecn=15 Participants	0	-
QTcF value > 500 msecn=15 Participants	0	-
QTcF increase from Baseline > 30 =< 60 msecn=15 Participants	1	-
QTcF increase from Baseline > 60 msecn=15 Participants	0	-
CVL-871 1.0 mgQTcF value > 450 =< 480 msecn=14 Participants	0	-
QTcF value > 480 =< 500 msecn=14 Participants	1	-
QTcF value > 500 msecn=14 Participants	0	-
QTcF increase from Baseline > 30 =< 60 msecn=14 Participants	0	-
QTcF increase from Baseline > 60 msecn=14 Participants	1	-
CVL-871 3.0 mgQTcF value > 450 =< 480 msecn=12 Participants	2	-
QTcF value > 480 =< 500 msecn=12 Participants	0	-
QTcF value > 500 msecn=12 Participants	0	-
QTcF increase from Baseline > 30 =< 60 msecn=12 Participants	1	-
QTcF increase from Baseline > 60 msecn=12 Participants	0	-

Primary/registry result

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Time frame:Baseline up to Week 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboSodium (mEq/L)(HYPO) CTCAE GRADE 3n=15 Participants	0	-
Hematologyn=15 Participants	0	-
Urinalysisn=15 Participants	0	-
CVL-871 1.0 mgSodium (mEq/L)(HYPO) CTCAE GRADE 3n=14 Participants	0	-
Hematologyn=14 Participants	0	-
Urinalysisn=14 Participants	0	-
CVL-871 3.0 mgSodium (mEq/L)(HYPO) CTCAE GRADE 3n=12 Participants	1	-
Hematologyn=12 Participants	0	-
Urinalysisn=12 Participants	0	-

Primary/registry result

Number of Participants With Clinically Significant Changes in Vital Sign Measurements

Time frame:Baseline up to Week 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboWeight Gain > 7% from Baselinen=15 Participants	0	-
Weight Loss > 7% from Baselinen=15 Participants	0	-
Systolic Blood Pressure (Sitting/Supine): Max Observed Value >160 mmHgn=15 Participants	1	-
Systolic Blood Pressure (Sitting/Supine): Max Increase of > 20 mmHg from Baselinen=15 Participants	4	-
Systolic Blood Pressure (Sitting/Supine): Min Observed Value < 90 mmHgn=15 Participants	0	-
Systolic Blood Pressure (Sitting/Supine): Greatest Decrease from Baseline > 20 mmHgn=15 Participants	3	-
Orthostatic Systolic Blood Pressure: Greatest Decrease Upon Standing ≥ 20 mmHgn=15 Participants	2	-
Orthostatic Systolic Blood Pressure: Max Increase Upon Standing ≥ 20 mmHgn=15 Participants	1	-
Diastolic Blood Pressure (Sitting/Supine): Max Observed Value > 100 mmHgn=15 Participants	0	-
Diastolic Blood Pressure (Sitting/Supine): Max Increase of > 10 mmHg from Baselinen=15 Participants	4	-
Diastolic Blood Pressure (Sitting/Supine): Min Observed Value < 50 mmHgn=15 Participants	0	-
Diastolic Blood Pressure (Sitting/Supine): Greatest Decrease from Baseline > 10 mmHgn=15 Participants	5	-
Orthostatic Diastolic Blood Pressure: Greatest Decrease Upon Standing ≥ 10 mmHgn=15 Participants	2	-
Orthostatic Diastolic Blood Pressure: Max Increase Upon Standing ≥ 10 mmHgn=15 Participants	3	-
Heart Rate (Sitting/Supine): Max Observed Value > 120 beats/minn=15 Participants	0	-
Heart Rate (Sitting/Supine): Min Observed Value < 50 beats/minn=15 Participants	2	-
CVL-871 1.0 mgWeight Gain > 7% from Baselinen=14 Participants	0	-
Weight Loss > 7% from Baselinen=14 Participants	0	-
Systolic Blood Pressure (Sitting/Supine): Max Observed Value >160 mmHgn=14 Participants	0	-
Systolic Blood Pressure (Sitting/Supine): Max Increase of > 20 mmHg from Baselinen=14 Participants	1	-
Systolic Blood Pressure (Sitting/Supine): Min Observed Value < 90 mmHgn=14 Participants	0	-
Systolic Blood Pressure (Sitting/Supine): Greatest Decrease from Baseline > 20 mmHgn=14 Participants	4	-
Orthostatic Systolic Blood Pressure: Greatest Decrease Upon Standing ≥ 20 mmHgn=14 Participants	3	-
Orthostatic Systolic Blood Pressure: Max Increase Upon Standing ≥ 20 mmHgn=14 Participants	6	-
Diastolic Blood Pressure (Sitting/Supine): Max Observed Value > 100 mmHgn=14 Participants	1	-
Diastolic Blood Pressure (Sitting/Supine): Max Increase of > 10 mmHg from Baselinen=14 Participants	5	-
Diastolic Blood Pressure (Sitting/Supine): Min Observed Value < 50 mmHgn=14 Participants	0	-
Diastolic Blood Pressure (Sitting/Supine): Greatest Decrease from Baseline > 10 mmHgn=14 Participants	3	-
Orthostatic Diastolic Blood Pressure: Greatest Decrease Upon Standing ≥ 10 mmHgn=14 Participants	6	-
Orthostatic Diastolic Blood Pressure: Max Increase Upon Standing ≥ 10 mmHgn=14 Participants	5	-
Heart Rate (Sitting/Supine): Max Observed Value > 120 beats/minn=14 Participants	0	-
Heart Rate (Sitting/Supine): Min Observed Value < 50 beats/minn=14 Participants	2	-
CVL-871 3.0 mgWeight Gain > 7% from Baselinen=12 Participants	0	-
Weight Loss > 7% from Baselinen=12 Participants	0	-
Systolic Blood Pressure (Sitting/Supine): Max Observed Value >160 mmHgn=12 Participants	0	-
Systolic Blood Pressure (Sitting/Supine): Max Increase of > 20 mmHg from Baselinen=12 Participants	2	-
Systolic Blood Pressure (Sitting/Supine): Min Observed Value < 90 mmHgn=12 Participants	0	-
Systolic Blood Pressure (Sitting/Supine): Greatest Decrease from Baseline > 20 mmHgn=12 Participants	6	-
Orthostatic Systolic Blood Pressure: Greatest Decrease Upon Standing ≥ 20 mmHgn=12 Participants	1	-
Orthostatic Systolic Blood Pressure: Max Increase Upon Standing ≥ 20 mmHgn=12 Participants	0	-
Diastolic Blood Pressure (Sitting/Supine): Max Observed Value > 100 mmHgn=12 Participants	0	-
Diastolic Blood Pressure (Sitting/Supine): Max Increase of > 10 mmHg from Baselinen=12 Participants	0	-
Diastolic Blood Pressure (Sitting/Supine): Min Observed Value < 50 mmHgn=12 Participants	1	-
Diastolic Blood Pressure (Sitting/Supine): Greatest Decrease from Baseline > 10 mmHgn=12 Participants	4	-
Orthostatic Diastolic Blood Pressure: Greatest Decrease Upon Standing ≥ 10 mmHgn=12 Participants	3	-
Orthostatic Diastolic Blood Pressure: Max Increase Upon Standing ≥ 10 mmHgn=12 Participants	1	-
Heart Rate (Sitting/Supine): Max Observed Value > 120 beats/minn=12 Participants	0	-
Heart Rate (Sitting/Supine): Min Observed Value < 50 beats/minn=12 Participants	2	-

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Baseline to Week 12

event count, event

Primary/registry result/low confidence

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

Time frame:Baseline to Week 12

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboPhysical Examinationsn=15 Participants	0	-
Neurological Examinationsn=15 Participants	0	-
CVL-871 1.0 mgPhysical Examinationsn=14 Participants	0	-
Neurological Examinationsn=14 Participants	0	-
CVL-871 3.0 mgPhysical Examinationsn=12 Participants	0	-
Neurological Examinationsn=12 Participants	0	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.