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

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 Overview

• Status: Terminated
• Conditions: Apathy in Dementia
• Intervention / Treatment: Drug: CVL-871 1.0 mg; Drug: CVL-871 3.0 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Calgary, Alberta
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 1J8
      • Victoria, British Columbia
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale, Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72114
      • Little Rock, Arkansas
  • California
    • San Diego, California, United States, 92123
      • San Diego, California
    • Santa Ana, California, United States, 92705
      • Santa Ana, California
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • New Haven, Connecticut
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Delray Beach, Florida
    • Miami, Florida, United States, 33122
      • Miami, Florida
    • Miami, Florida, United States, 33180
      • Miami, Florida
    • Orlando, Florida, United States, 32819
      • Orlando, Florida
    • Wellington, Florida, United States, 33414
      • Wellington, Florida
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Decatur, Georgia
  • Massachusetts
    • Plymouth, Massachusetts, United States, 02360
      • Plymouth, Massachusetts
  • New York
    • Staten Island, New York, United States, 10312
      • Staten Island, New York
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Columbus, Ohio
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington, Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Charleston, South Carolina
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Fairfax, Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CVL-871 1.0 mg; 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.	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)
Experimental: CVL-871 3.0 mg; 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.	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)
Placebo Comparator: Placebo; Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period.	Drug: Placebo; Placebo QD, oral (tablet), once per day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	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.	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.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline to Week 6 and Week 12

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Actual): February 12, 2025
• Study Completion (Actual): February 12, 2025

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Dementia; Apathy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dementia; Lethargy
• Other Study ID Numbers: CVL-871-2001; IND 150,086 (Other Identifier: IND)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No