A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
NCT ID: NCT04958031
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2021-06-22
2025-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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
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.
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
Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period.
Placebo
Placebo QD, oral (tablet), once per day for 12 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Clinically significant apathy
* Mild to Moderate Dementia (AD, FTD, VAD, or DLB)
Exclusion Criteria
* Other neurological disorders (other than AD, FTD, VAD, or DLB)
50 Years
85 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Fairfax, Virginia
Fairfax, Virginia, United States
Calgary, Alberta
Calgary, Alberta, Canada
Scottsdale, Arizona
Scottsdale, Arizona, United States
Little Rock, Arkansas
Little Rock, Arkansas, United States
San Diego, California
San Diego, California, United States
Santa Ana, California
Santa Ana, California, United States
New Haven, Connecticut
New Haven, Connecticut, United States
Delray Beach, Florida
Delray Beach, Florida, United States
Miami, Florida
Miami, Florida, United States
Miami, Florida
Miami, Florida, United States
Orlando, Florida
Orlando, Florida, United States
Wellington, Florida
Wellington, Florida, United States
Decatur, Georgia
Decatur, Georgia, United States
Plymouth, Massachusetts
Plymouth, Massachusetts, United States
Staten Island, New York
Staten Island, New York, United States
Columbus, Ohio
Columbus, Ohio, United States
Abington, Pennsylvania
Abington, Pennsylvania, United States
Charleston, South Carolina
Charleston, South Carolina, United States
Victoria, British Columbia
Victoria, British Columbia, Canada
Toronto, Ontario
Toronto, Ontario, Canada
Countries
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Other Identifiers
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IND 150,086
Identifier Type: OTHER
Identifier Source: secondary_id
CVL-871-2001
Identifier Type: -
Identifier Source: org_study_id
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