Clinical trial NCT04958031: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Apathy in Dementia
Keywords: Dementia
Apathy
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to Week 16 (follow-up period)
measure: Incidence of clinically significant changes in electrocardiogram (ECG) results
timeFrame: Baseline up to Week 16 or early termination (ET)
measure: Incidence of clinically significant changes in clinical laboratory results
timeFrame: Baseline up to Week 14 or early termination (ET)
measure: Incidence in clinically significant changes in vital sign measurements
timeFrame: Baseline up to Week 14 or early termination (ET)
measure: Incidence of clinically significant changes in physical and neurological examination results
timeFrame: Screening up to Week 16 or early termination (ET)
measure: Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)
timeFrame: Baseline up to Week 14 (follow up period)
Secondary outcomes:
measure: Change from baseline in the Dementia Apathy Interview and Rating (DAIR) score
timeFrame: Baseline up to Week 12 or early termination (ET)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale, Arizona
state: Arizona
city: Little Rock
country: United States
facility: Little Rock, Arkansas
state: Arkansas
city: San Diego
country: United States
facility: San Diego, California
state: California
city: Santa Ana
country: United States
facility: Santa Ana, California
state: California
city: New Haven
country: United States
facility: New Haven, Connecticut
state: Connecticut
city: Delray Beach
country: United States
facility: Delray Beach, Florida
state: Florida
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: Orlando
country: United States
facility: Orlando, Florida
state: Florida
city: Wellington
country: United States
facility: Wellington, Florida
state: Florida
city: Decatur
country: United States
facility: Decatur, Georgia
state: Georgia
city: Plymouth
country: United States
facility: Plymouth, Massachusetts
state: Massachusetts
city: Staten Island
country: United States
facility: Staten Island, New York
state: New York
city: Columbus
country: United States
facility: Columbus, Ohio
state: Ohio
city: Abington
country: United States
facility: Abington, Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston, South Carolina
state: South Carolina
city: Fairfax
country: United States
facility: Fairfax, Virginia
state: Virginia
city: Calgary
country: Canada
facility: Calgary, Alberta
state: Alberta
city: Victoria
country: Canada
facility: Victoria, British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: Toronto, Ontario
state: Ontario
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: