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CVL-871 for Dementia-related Apathy

Phase 2
Recruiting
Research Sponsored by Cerevel Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets diagnostic criteria for apathy in neurocognitive disorders
Clinically significant apathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 16 or early termination (et)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in treating apathy in patients with dementia.

Who is the study for?
This trial is for individuals with mild to moderate dementia (Alzheimer's, Frontotemporal, Vascular, or Lewy Body) who show significant signs of apathy. It's not suitable for those with other major psychiatric or neurological conditions besides the specified types of dementia.Check my eligibility
What is being tested?
The study tests CVL-871 at two different doses (1.0 mg and 3.0 mg) against a placebo to see if it's safe and can improve symptoms of apathy in dementia patients. Participants will be randomly assigned to one of these treatments.See study design
What are the potential side effects?
Potential side effects are not detailed here but generally could include gastrointestinal issues, headaches, dizziness, or mood changes as commonly seen with medications affecting brain function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with apathy related to a brain disorder.
Select...
You have significant lack of interest or motivation that affects your daily life.
Select...
I have been diagnosed with a form of dementia that is not severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 16 or early termination (et)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 16 or early termination (et) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Incidence in clinically significant changes in vital sign measurements
+3 more
Secondary outcome measures
Change from baseline in the Dementia Apathy Interview and Rating (DAIR) score

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: CVL-871 3.0 mgExperimental Treatment1 Intervention
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.
Group II: CVL-871 1.0 mgExperimental Treatment1 Intervention
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.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period.

Find a Location

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,640 Total Patients Enrolled
Ann Dandurand, MDStudy DirectorCerevel Therapeutics, LLC
6 Previous Clinical Trials
525 Total Patients Enrolled
Eric Pozsgai, PhDStudy DirectorCerevel Therapeutics, LLC

Media Library

CVL-871 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04958031 — Phase 2
Dementia Research Study Groups: CVL-871 1.0 mg, CVL-871 3.0 mg, Placebo
Dementia Clinical Trial 2023: CVL-871 Highlights & Side Effects. Trial Name: NCT04958031 — Phase 2
CVL-871 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958031 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently open for the trial?

"Affirmative. The clinicaltrials.gov portal indicates that this study is still seeking participants, which was initially listed on June 22nd 2021 and updated lastly on September 9th 2022. 75 volunteers are expected to be recruited in total from across the specified 22 trial sites."

Answered by AI

For what kind of individuals is this medical investigation best suited?

"This trial requires participants to be aged between 50 and 85, with a diagnosis of apathy. Approximately 75 people are being enrolled in this study."

Answered by AI

What is the geographical reach of this experiment?

"Patients are currently being sought out of a total of 22 sites, including Little Rock, Victoria and Charleston. It is advised to select the closest location in order to mitigate any travel requirements if one joins this trial."

Answered by AI

Are individuals aged thirty and above accepted into this trial?

"This trial is welcoming participants between the age of 50 and 85."

Answered by AI

What is the scope of recruitment for this trial?

"The trial, overseen by Cerevel Therapeutics LLC, necessitates the recruitment of 75 eligible patients from Little Rock Arkansas and Victoria British Columbia."

Answered by AI

Is CVL-871 1.0 mg a reliable treatment option for patients?

"Our team at Power assigned CVL-871 1.0 mg a score of 2, as Phase 2 trials provide only limited safety data and none regarding efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Miami, Florida
Victoria, British Columbia
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Miami, Florida: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
2021. "A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04958031.
~10 spots leftby Oct 2024
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