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

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

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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