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CVL-871 1.0 mg for Dementia

Toronto, Ontario, Toronto, Canada
DementiaCVL-871 1.0 mg - Drug
Eligibility
50 - 85
All Sexes

Study Summary

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

Eligible Conditions
  • Dementia Apathy

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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1
SM17
1
VK0214
1
Drug: CVL-354

Study Objectives

6 Primary · 1 Secondary · Reporting Duration: Baseline up to Week 16 or early termination (ET)

Week 12
Change from baseline in the Dementia Apathy Interview and Rating (DAIR) score
Week 14
Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Week 14
Incidence in clinically significant changes in vital sign measurements
Incidence of clinically significant changes in clinical laboratory results
Week 16
Incidence of clinically significant changes in electrocardiogram (ECG) results
Week 16
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Week 16
Incidence of clinically significant changes in physical and neurological examination results

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
SM17
1
VK0214
1
Drug: CVL-354

Trial Design

3 Treatment Groups

CVL-871 3.0 mg
1 of 3
CVL-871 1.0 mg
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

75 Total Participants · 3 Treatment Groups

Primary Treatment: CVL-871 1.0 mg · Has Placebo Group · Phase 2

CVL-871 3.0 mg
Drug
Experimental Group · 1 Intervention: CVL-871 3.0 mg · Intervention Types: Drug
CVL-871 1.0 mg
Drug
Experimental Group · 1 Intervention: CVL-871 1.0 mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to week 16 or early termination (et)

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
27 Previous Clinical Trials
4,780 Total Patients Enrolled
Ann Dandurand, MDStudy DirectorCerevel Therapeutics, LLC
4 Previous Clinical Trials
394 Total Patients Enrolled
Eric Pozsgai, PhDStudy DirectorCerevel Therapeutics, LLC

Eligibility Criteria

Age 50 - 85 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have significant lack of interest or motivation that affects your daily life.
You have mild to moderate memory and thinking problems such as forgetfulness, confusion, or having trouble with daily tasks.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Are individuals aged thirty and above accepted into this trial?

"This trial is welcoming participants between the age of 50 and 85." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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