A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
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|ClinicalTrials.gov Identifier: NCT04958031|
Recruitment Status : Recruiting
First Posted : July 12, 2021
Last Update Posted : September 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Apathy in Dementia||Drug: CVL-871 1.0 mg Drug: CVL-871 3.0 mg Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are assigned to one of two or more groups in parallel for the duration of the study|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||• Double Blind: two or more parties are unaware of the intervention assignment (Blinded: Subject, Caregiver, Investigator)|
|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|
|Actual Study Start Date :||June 22, 2021|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: 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.
Drug: 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)
Experimental: 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.
Drug: 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 Comparator: Placebo
Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period.
Placebo QD, oral (tablet), once per day for 12 weeks
- Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug up to Week 16 (follow-up period) ]Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE)
- Incidence of clinically significant changes in electrocardiogram (ECG) results [ Time Frame: Baseline up to Week 16 or early termination (ET) ]Assessment of clinically significant changes in QT intervals measured by 12-lead ECG recording after the participant has been supine and at rest for at least 5 minutes
- Incidence of clinically significant changes in clinical laboratory results [ Time Frame: Baseline up to Week 14 or early termination (ET) ]
- Incidence in clinically significant changes in vital sign measurements [ Time Frame: Baseline up to Week 14 or early termination (ET) ]Assessment of clinically significant changes in vital signs including temperature, systolic and diastolic blood pressure, and heart rate.
- Incidence of clinically significant changes in physical and neurological examination results [ Time Frame: Screening up to Week 16 or early termination (ET) ]
- Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS) [ Time Frame: Baseline up to Week 14 (follow up period) ]The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
- Change from baseline in the Dementia Apathy Interview and Rating (DAIR) score [ Time Frame: Baseline up to Week 12 or early termination (ET) ]The Dementia Apathy Interview Rating (DAIR) is a 16-item structured interview with the primary caregiver designed to assess illness-related changes in motivation, emotional responsiveness, and engagement. The total apathy score is a sum of all items reflecting change (items for which there is no change are not rated), divided by the number of items completed, with higher scores representing greater average apathy. In addition, the frequency of these behaviors is assessed; higher scores represent more frequent apathy-related behavior.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04958031
|Study Director:||Eric Pozsgai, PhD||Cerevel Therapeutics, LLC|