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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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Cerevel Therapeutics

Status and phase

Enrolling
Phase 2

Conditions

Apathy in Dementia

Treatments

Drug: CVL-871 3.0 mg
Drug: Placebo
Drug: CVL-871 1.0 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT04958031
CVL-871-2001
IND 150,086 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

75 participants in 3 patient groups, including a placebo group

CVL-871 1.0 mg
Experimental group
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.
Treatment:
Drug: CVL-871 1.0 mg
CVL-871 3.0 mg
Experimental group
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.
Treatment:
Drug: CVL-871 3.0 mg
Placebo
Placebo Comparator group
Description:
Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period.
Treatment:
Drug: Placebo

Trial contacts and locations

28

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Central trial contact

Cerevel Clinical Trial Support

Data sourced from clinicaltrials.gov

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