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Trial record 1 of 1 for:    CVL-871-2001
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A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy

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ClinicalTrials.gov Identifier: NCT04958031
Recruitment Status : Recruiting
First Posted : July 12, 2021
Last Update Posted : September 10, 2022
Sponsor:
Information provided by (Responsible Party):
Cerevel Therapeutics, LLC

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.

Condition or disease Intervention/treatment Phase
Apathy in Dementia Drug: CVL-871 1.0 mg Drug: CVL-871 3.0 mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: • Double Blind: two or more parties are unaware of the intervention assignment (Blinded: Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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




Primary Outcome Measures :
  1. 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)

  2. 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

  3. Incidence of clinically significant changes in clinical laboratory results [ Time Frame: Baseline up to Week 14 or early termination (ET) ]
  4. 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.

  5. Incidence of clinically significant changes in physical and neurological examination results [ Time Frame: Screening up to Week 16 or early termination (ET) ]
  6. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04958031


Locations
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Sponsors and Collaborators
Cerevel Therapeutics, LLC
Investigators
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Study Director: Eric Pozsgai, PhD Cerevel Therapeutics, LLC
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Responsible Party: Cerevel Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04958031    
Other Study ID Numbers: CVL-871-2001
IND 150,086 ( Other Identifier: IND )
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: September 10, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cerevel Therapeutics, LLC:
Dementia
Apathy
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders