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

Apathy in Dementia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04958031
• Other study ID #: CVL-871-2001
• Secondary ID: IND 150,086
• Status: Recruiting
• Phase: Phase 2
• Start date: June 22, 2021
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Cerevel Therapeutics, LLC
• Contact: Cerevel Clinical Trial Support
• Email: cerevelclinicaltrials[@]cerevel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apathy in Dementia
• Dementia

Intervention

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

Locations

Country	Name	City	State
Canada	Calgary, Alberta	Calgary	Alberta
Canada	Toronto, Ontario	Toronto	Ontario
Canada	Victoria, British Columbia	Victoria	British Columbia
United States	Abington, Pennsylvania	Abington	Pennsylvania
United States	Allentown, Pennsylvania	Allentown	Pennsylvania
United States	Boca Raton, Florida	Boca Raton	Florida
United States	Charleston, South Carolina	Charleston	South Carolina
United States	Columbus, Ohio	Columbus	Ohio
United States	Decatur, Georgia	Decatur	Georgia
United States	Delray Beach, Florida	Delray Beach	Florida
United States	Doral, Florida	Doral	Florida
United States	Elk Grove Village, Illinois	Elk Grove Village	Illinois
United States	Fairfax, Virginia	Fairfax	Virginia
United States	Little Rock, Arkansas	Little Rock	Arkansas
United States	Miami, Florida	Miami	Florida
United States	Miami, Florida	Miami	Florida
United States	Naples, Florida	Naples	Florida
United States	New Brunswick, New Jersey	New Brunswick	New Jersey
United States	New Haven, Connecticut	New Haven	Connecticut
United States	Orlando, Florida	Orlando	Florida
United States	Plymouth, Massachusetts	Plymouth	Massachusetts
United States	San Diego, California	San Diego	California
United States	Santa Ana, California	Santa Ana	California
United States	Scottsdale, Arizona	Scottsdale	Arizona
United States	Staten Island, New York	Staten Island	New York
United States	Suwanee, Georgia	Suwanee	Georgia
United States	Wellington, Florida	Wellington	Florida
United States	Yorba Linda, California	Yorba Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Cerevel Therapeutics, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From first dose of study drug up to Week 16 (follow-up period)
Primary	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	Baseline up to Week 16 or early termination (ET)
Primary	Incidence of clinically significant changes in clinical laboratory results		Baseline up to Week 14 or early termination (ET)
Primary	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.	Baseline up to Week 14 or early termination (ET)
Primary	Incidence of clinically significant changes in physical and neurological examination results		Screening up to Week 16 or early termination (ET)
Primary	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).	Baseline up to Week 14 (follow up period)
Secondary	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.	Baseline up to Week 12 or early termination (ET)