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

April 17, 2024 updated by: Cerevel Therapeutics, LLC

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Terminated
        • Calgary, Alberta
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
    • Ontario
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Withdrawn
        • Scottsdale, Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72114
        • Terminated
        • Little Rock, Arkansas
    • California
      • San Diego, California, United States, 92123
        • Terminated
        • San Diego, California
      • Santa Ana, California, United States, 92705
        • Terminated
        • Santa Ana, California
      • Yorba Linda, California, United States, 92886
        • Withdrawn
        • Yorba Linda, California
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Withdrawn
        • Boca Raton, Florida
      • Delray Beach, Florida, United States, 33445
        • Terminated
        • Delray Beach, Florida
      • Doral, Florida, United States, 33126
        • Withdrawn
        • Doral, Florida
      • Miami, Florida, United States, 33122
        • Terminated
        • Miami, Florida
      • Miami, Florida, United States, 33180
        • Terminated
        • Miami, Florida
      • Naples, Florida, United States, 34105
        • Withdrawn
        • Naples, Florida
      • Orlando, Florida, United States, 32819
        • Terminated
        • Orlando, Florida
      • Wellington, Florida, United States, 33414
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Terminated
        • Decatur, Georgia
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Withdrawn
        • Elk Grove Village, Illinois
    • Massachusetts
      • Plymouth, Massachusetts, United States, 02360
        • Terminated
        • Plymouth, Massachusetts
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Withdrawn
        • New Brunswick, New Jersey
    • New York
      • Staten Island, New York, United States, 10312
        • Terminated
        • Staten Island, New York
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Terminated
        • Columbus, Ohio
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
      • Allentown, Pennsylvania, United States, 18104
        • Withdrawn
        • Allentown, Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Recruiting
        • Charleston, South Carolina
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Terminated
        • Fairfax, Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Time Frame: From first dose of study drug up to Week 16 (follow-up period)
Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE)
From first dose of study drug up to Week 16 (follow-up period)
Incidence of clinically significant changes in electrocardiogram (ECG) results
Time Frame: Baseline up to Week 16 or early termination (ET)
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 16 or early termination (ET)
Incidence of clinically significant changes in clinical laboratory results
Time Frame: Baseline up to Week 14 or early termination (ET)
Baseline up to Week 14 or early termination (ET)
Incidence in clinically significant changes in vital sign measurements
Time Frame: Baseline up to Week 14 or early termination (ET)
Assessment of clinically significant changes in vital signs including temperature, systolic and diastolic blood pressure, and heart rate.
Baseline up to Week 14 or early termination (ET)
Incidence of clinically significant changes in physical and neurological examination results
Time Frame: Screening up to Week 16 or early termination (ET)
Screening up to Week 16 or early termination (ET)
Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Time Frame: Baseline up to Week 14 (follow up period)
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).
Baseline up to Week 14 (follow up period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the Dementia Apathy Interview and Rating (DAIR) score
Time Frame: Baseline up to Week 12 or early termination (ET)
The Dementia Apathy Interview Rating (DAIR) is a 16-item structured interview with the primary caregiver designed to assess illness-related changes in motivation, emotional responsiveness, and engagement. The total apathy score is a sum of all items reflecting change (items for which there is no change are not rated), divided by the number of items completed, with higher scores representing greater average apathy. In addition, the frequency of these behaviors is assessed; higher scores represent more frequent apathy-related behavior.
Baseline up to Week 12 or early termination (ET)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerevel Therapeutics, LLC

Investigators

  • Study Director: Eric Pozsgai, PhD, Cerevel Therapeutics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2021

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

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 (Estimated)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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