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

Primary Purpose

Apathy in Dementia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CVL-871 1.0 mg
CVL-871 3.0 mg
Placebo
Sponsored by
Cerevel Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apathy in Dementia focused on measuring Dementia, Apathy

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Scottsdale, ArizonaRecruiting
  • Little Rock, ArkansasRecruiting
  • San Diego, CaliforniaRecruiting
  • Santa Ana, CaliforniaRecruiting
  • Yorba Linda, CaliforniaRecruiting
  • New Haven, ConnecticutRecruiting
  • Boca Raton, FloridaRecruiting
  • Delray Beach, FloridaRecruiting
  • Doral, FloridaRecruiting
  • Miami, FloridaRecruiting
  • Miami, FloridaRecruiting
  • Naples, FloridaRecruiting
  • Orlando, FloridaRecruiting
  • Wellington, FloridaRecruiting
  • Decatur, GeorgiaRecruiting
  • Elk Grove Village, IllinoisRecruiting
  • Plymouth, MassachusettsRecruiting
  • New Brunswick, New JerseyRecruiting
  • Staten Island, New YorkRecruiting
  • Columbus, OhioRecruiting
  • Abington, PennsylvaniaRecruiting
  • Allentown, Pennsylvania
  • Charleston, South CarolinaRecruiting
  • Fairfax, VirginiaRecruiting
  • Calgary, AlbertaRecruiting
  • Victoria, British ColumbiaRecruiting
  • Toronto, OntarioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CVL-871 1.0 mg

CVL-871 3.0 mg

Placebo

Arm Description

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.

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.

Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period.

Outcomes

Primary Outcome Measures

Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE)
Incidence of clinically significant changes in electrocardiogram (ECG) results
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
Incidence of clinically significant changes in clinical laboratory results
Incidence in clinically significant changes in vital sign measurements
Assessment of clinically significant changes in vital signs including temperature, systolic and diastolic blood pressure, and heart rate.
Incidence of clinically significant changes in physical and neurological examination results
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).

Secondary Outcome Measures

Change from baseline in the Dementia Apathy Interview and Rating (DAIR) score
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.

Full Information

First Posted
June 8, 2021
Last Updated
February 28, 2023
Sponsor
Cerevel Therapeutics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04958031
Brief Title
A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerevel Therapeutics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apathy in Dementia
Keywords
Dementia, Apathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
ParticipantCare ProviderInvestigator
Masking Description
• Double Blind: two or more parties are unaware of the intervention assignment (Blinded: Subject, Caregiver, Investigator)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CVL-871 1.0 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
CVL-871 3.0 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period.
Intervention Type
Drug
Intervention Name(s)
CVL-871 1.0 mg
Intervention Description
CVL-871 1.0 mg, oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-7)
Intervention Type
Drug
Intervention Name(s)
CVL-871 3.0 mg
Intervention Description
CVL-871 3.0 mg QD oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-21)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo QD, oral (tablet), once per day for 12 weeks
Primary Outcome Measure Information:
Title
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Description
Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE)
Time Frame
From first dose of study drug up to Week 16 (follow-up period)
Title
Incidence of clinically significant changes in electrocardiogram (ECG) results
Description
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
Time Frame
Baseline up to Week 16 or early termination (ET)
Title
Incidence of clinically significant changes in clinical laboratory results
Time Frame
Baseline up to Week 14 or early termination (ET)
Title
Incidence in clinically significant changes in vital sign measurements
Description
Assessment of clinically significant changes in vital signs including temperature, systolic and diastolic blood pressure, and heart rate.
Time Frame
Baseline up to Week 14 or early termination (ET)
Title
Incidence of clinically significant changes in physical and neurological examination results
Time Frame
Screening up to Week 16 or early termination (ET)
Title
Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Description
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).
Time Frame
Baseline up to Week 14 (follow up period)
Secondary Outcome Measure Information:
Title
Change from baseline in the Dementia Apathy Interview and Rating (DAIR) score
Description
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.
Time Frame
Baseline up to Week 12 or early termination (ET)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Pozsgai, PhD
Organizational Affiliation
Cerevel Therapeutics, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale, Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenna Leger
Phone
480-566-9090
Email
jleger@clinicalendpoints.com
Facility Name
Little Rock, Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Parkes
Phone
501-257-2504
Email
christopher.parkes@va.gov
Facility Name
San Diego, California
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Nuñez
Phone
858-836-8350
Email
Maria.Nunez@sharp.com
Facility Name
Santa Ana, California
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorrie Bisesi
Phone
714-542-3008
Email
lbisesi@syrentis.com
Facility Name
Yorba Linda, California
City
Yorba Linda
State/Province
California
ZIP/Postal Code
92886
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hemangini Patel
Phone
714-393-4539
Email
hemangini9@aol.com
Facility Name
New Haven, Connecticut
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Gunnoud
Phone
203-764-8100
Email
carol.gunnoud@yale.edu
Facility Name
Boca Raton, Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle DeMaria
Phone
561-939-0333
Email
gabrielle@sfmresearch.com
Facility Name
Delray Beach, Florida
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Hudson
Phone
561-374-8461
Email
ahudson@ergclinical.com
Facility Name
Doral, Florida
City
Doral
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zamora Anaeli
Phone
786-800-9512
Email
azamora.lifewellresearch@gmail.com
Facility Name
Miami, Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliet Perez
Phone
305-392-0279
Email
jperez@pcrinstitute.com
Facility Name
Miami, Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Rodriquez
Phone
305-751-8626
Ext
64108
Email
jrodriguez4@miamijewishhealth.org
Facility Name
Naples, Florida
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Gonzalez
Phone
239-434-0332
Email
dgonzalez@collierneurologic.com
Facility Name
Orlando, Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candice Montros
Phone
407-705-3471
Email
candice.montros@headlandsresearch.com
Facility Name
Wellington, Florida
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Morera
Phone
561-209-2400
Email
amorera@researchalz.com
Facility Name
Decatur, Georgia
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey Chacona
Phone
404-537-1281
Email
casey.chacona@iresearchatlanta.com
Facility Name
Elk Grove Village, Illinois
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scarlett During
Phone
847-472-2217
Email
scarlett.during@amitahealth.org
Facility Name
Plymouth, Massachusetts
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Kearney
Phone
508-746-5060
Email
elainek@dsmmdpc.com
Facility Name
New Brunswick, New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie McCloskey
Phone
732-235-5965
Email
mcclosda@rwjms.rutgers.edu
Facility Name
Staten Island, New York
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priya Selvarajah
Phone
718-317-5522
Email
pselvarajah@ergclinical.com
Facility Name
Columbus, Ohio
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Icenhour
Phone
614-293-4969
Email
jennifer.icenhour@osumc.edu
Facility Name
Abington, Pennsylvania
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clifton Blackwood
Phone
215-957-9250
Email
cliftonblackwood.ana@gmail.com
Facility Name
Allentown, Pennsylvania
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Individual Site Status
Withdrawn
Facility Name
Charleston, South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Williams
Phone
843-724-2302
Ext
6375
Email
arthur.williams1@va.gov
Facility Name
Fairfax, Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Bland
Phone
703-520-9703
Email
mbland@re-cognitionhealth.com
Facility Name
Calgary, Alberta
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramnik Sekhon
Phone
403-210-7737
Email
ramnik.sekhon@ucalgary.ca
Facility Name
Victoria, British Columbia
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Bazett
Phone
250-370-8111
Email
sheila.bazett@islandhealth.ca
Facility Name
Toronto, Ontario
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby Li
Phone
416-480-6100
Email
abby.li@sunnybrook.ca

12. IPD Sharing Statement

Learn more about this trial

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

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