What is the mechanism of action of this treatment?

Common treatments for dementia include cholinesterase inhibitors (e.g., donepezil, rivastigmine), which work by increasing levels of acetylcholine in the brain to improve cognitive function, and NMDA receptor antagonists (e.g., memantine), which regulate glutamate activity to protect against excitotoxicity and neuronal damage. Dopaminergic agents, such as those targeting dopamine receptors, are also being explored. CVL-871, a dopamine D1/D5 receptor partial agonist, aims to modulate dopaminergic signaling, which may help alleviate symptoms of apathy and improve motivation and cognitive function in dementia patients. Understanding these mechanisms is crucial as they address different aspects of neurochemical imbalances in dementia, potentially leading to more effective and targeted treatments.

What side effects are associated with this type of intervention?

Common treatments for dementia, such as dopaminergic medications and cholinesterase inhibitors, have a range of side effects. Dopaminergic medications, while potentially improving short-term memory, can cause mild and variable cognitive effects, and may lead to dyskinesia and motor fluctuations. Cholinesterase inhibitors can modestly improve cognitive function but often cause gastrointestinal issues like nausea, vomiting, and diarrhea. Cognitive enhancers like piracetam and acetyl-L-carnitine may show some benefits but can also lead to adverse reactions such as headaches and dizziness. Overall, while these treatments can offer some cognitive benefits, they are often accompanied by a variety of side effects that need to be managed.

What prior FDA approvals exist?

FDA-approved treatments for dementia primarily include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and the NMDA receptor antagonist memantine. These drugs aim to improve cognitive function and manage symptoms but do not modify disease progression. While CVL-871, a Dopamine D1/D5 receptor partial agonist, is being studied for dementia-related apathy, there are no current FDA-approved dementia treatments specifically targeting dopamine receptors in a similar manner.

What other types of research exist?

Promising alternatives to CVL-871 for dementia patients include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, which have shown efficacy in improving cognitive function and managing symptoms of dementia. Additionally, memantine, an NMDA receptor antagonist, is another option that can be used alone or in combination with cholinesterase inhibitors. These treatments are well-studied and widely used in clinical practice.

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CVL-871 for Dementia-related Apathy

Phase 2

Waitlist Available

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)

Summary

This trial is testing a new medication called CVL-871 to see if it is safe and can help people with dementia who lack interest or motivation. The goal is to find out if the medication can reduce their apathy.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to week 16 or early termination (et)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

+1 more

Secondary study objectives

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for dementia include cholinesterase inhibitors (e.g., donepezil, rivastigmine), which work by increasing levels of acetylcholine in the brain to improve cognitive function, and NMDA receptor antagonists (e.g., memantine), which regulate glutamate activity to protect against excitotoxicity and neuronal damage. Dopaminergic agents, such as those targeting dopamine receptors, are also being explored. CVL-871, a dopamine D1/D5 receptor partial agonist, aims to modulate dopaminergic signaling, which may help alleviate symptoms of apathy and improve motivation and cognitive function in dementia patients. Understanding these mechanisms is crucial as they address different aspects of neurochemical imbalances in dementia, potentially leading to more effective and targeted treatments.

Recent advances in the management of neuropsychiatric symptoms in dementia.Alpha-7 nicotinic agonists for cognitive deficits in neuropsychiatric disorders: A translational meta-analysis of rodent and human studies.Pharmacological recommendations for the symptomatic treatment of dementia: the Canadian Consensus Conference on the Diagnosis and Treatment of Dementia 2012.