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CVL-871 in Dementia-Related Apathy
NCT04958031Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2021
- Primary completion
- Feb 2025
- Countries
- 2
- Sponsor
- AbbVie Inc.
- Modality
- Small Molecules
- Drugs
- razpipadon
- Conditions
- Dementia
01
Overview
Phase 2, randomised, double-blind trial of razpipadon in Dementia, sponsored by AbbVie Inc. Primary endpoints: Number of Participants With Adverse Events at 16 weeks, Number of Participants With Clinically Significant Changes in Electrocardiogram at 12 weeks and 4 more. Started Jun 2021; status: terminated.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Patients with mild to moderate dementia (AD, FTD, VAD, or DLB) and clinically significant apathy.
04
Endpoints
Primary
Number of Participants With Adverse Events
Number of Participants With Clinically Significant Changes in Electrocardiogram
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Secondary
Change From Baseline in the Neuropsychiatric Inventory - Clinician Apathy Score
Change From Baseline in the Neuropsychiatric Inventory Apathy Score
Change From Baseline in the Dementia Apathy Interview and Rating Score
Change From Baseline in the Apathy Evaluation Scale-Clinician Score
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