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

NCT04958031 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: CVL-871-2001IND 150,086
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 20

Brief 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.

Conditions

Apathy in Dementia

Keywords

Dementia; Apathy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

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

  Baseline to Week 6 and Week 12

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

  Baseline to Week 6 and Week 12

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

  Baseline to Week 6 and Week 12

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

  Baseline to Week 6 and Week 12

Study Arms (3)

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.

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.

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.

Drug: Placebo

Interventions

CVL-871 3.0 mg DRUG

CVL-871 3.0 mg QD oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-21)

CVL-871 3.0 mg

Placebo DRUG

Placebo QD, oral (tablet), once per day for 12 weeks

Placebo

CVL-871 1.0 mg DRUG

CVL-871 1.0 mg, oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-7)

CVL-871 1.0 mg

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets diagnostic criteria for apathy in neurocognitive disorders
• Clinically significant apathy
• Mild to Moderate Dementia (AD, FTD, VAD, or DLB)

You may not qualify if:

• Other significant psychiatric disorder(s)
• Other neurological disorders (other than AD, FTD, VAD, or DLB)

Sponsors & Collaborators

• AbbVie: lead

Study Sites (20)

Scottsdale, Arizona

Scottsdale, Arizona, 85258, United States

Location

Little Rock, Arkansas

Little Rock, Arkansas, 72114, United States

Location

San Diego, California

San Diego, California, 92123, United States

Location

Santa Ana, California

Santa Ana, California, 92705, United States

Location

New Haven, Connecticut

New Haven, Connecticut, 06510, United States

Location

Delray Beach, Florida

Delray Beach, Florida, 33445, United States

Location

Miami, Florida

Miami, Florida, 33122, United States

Location

Miami, Florida

Miami, Florida, 33180, United States

Location

Orlando, Florida

Orlando, Florida, 32819, United States

Location

Wellington, Florida

Wellington, Florida, 33414, United States

Location

Decatur, Georgia

Decatur, Georgia, 30030, United States

Location

Plymouth, Massachusetts

Plymouth, Massachusetts, 02360, United States

Location

Staten Island, New York

Staten Island, New York, 10312, United States

Location

Columbus, Ohio

Columbus, Ohio, 43210, United States

Location

Abington, Pennsylvania

Abington, Pennsylvania, 19001, United States

Location

Charleston, South Carolina

Charleston, South Carolina, 29403, United States

Location

Fairfax, Virginia

Fairfax, Virginia, 22031, United States

Location

Calgary, Alberta

Calgary, Alberta, T2N 4N1, Canada

Location

Victoria, British Columbia

Victoria, British Columbia, V8R 1J8, Canada

Location

Toronto, Ontario

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Dementia; Lethargy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: • Double Blind: two or more parties are unaware of the intervention assignment (Blinded: Participant, Caregiver, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 12, 2021
• Study Start: June 22, 2021
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-01

Locations

CA (3); US (17)