CVL-871 for Dementia-related Apathy

No longer recruiting at 25 trial locations

Overseen By Cerevel Clinical Trial Support

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: Other psychiatric, neurological disorders

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CVL-871 to determine its effectiveness in addressing apathy in individuals with dementia. Apathy, characterized by a lack of interest or motivation, can complicate daily life. Participants are divided into two groups receiving different doses of CVL-871 and one group receiving a placebo (a pill with no active medicine) for comparison. Individuals diagnosed with mild to moderate dementia and noticeable apathy may be suitable for this study. The trial aims to assess the safety of CVL-871 and its impact on reducing apathy symptoms. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is investigating the safety of CVL-871 for individuals with dementia-related apathy. Previous studies primarily assessed its tolerability, focusing on participants' experiences and any side effects. However, detailed information about specific side effects and their frequency remains unavailable.

This trial is in Phase 2, indicating that the treatment has already passed some initial safety tests. These early tests suggested that CVL-871 is likely safe enough for broader testing. Nonetheless, further research is necessary to understand its effects, particularly for those with dementia-related apathy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dementia-related apathy?

Unlike the standard treatments for dementia-related apathy, which often include medications like antidepressants or psychostimulants, CVL-871 targets dopamine D1/D5 receptors. This unique mechanism is thought to enhance motivation and engagement without the side effects commonly associated with traditional treatments. Researchers are excited about CVL-871 because it represents a new approach that potentially offers improved symptom management and quality of life for patients with dementia-related apathy.

What evidence suggests that CVL-871 could be an effective treatment for dementia-related apathy?

This trial will compare different doses of CVL-871 with a placebo to assess its potential benefits for people with dementia-related apathy. Research has shown that CVL-871 might help people with dementia who lack interest or motivation. While more information is needed, this drug targets specific brain areas related to motivation and reward. Early studies suggest that CVL-871 can affect these brain areas, possibly helping people become more engaged in daily activities. Although further research is necessary, focusing on these brain pathways offers hope that CVL-871 could benefit those with dementia-related apathy. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have significant lack of interest or motivation that affects your daily life.

I have been diagnosed with a form of dementia that is not severe.

I have been diagnosed with apathy related to a brain disorder.

Exclusion Criteria

You have a serious mental health condition other than the one being studied.

I do not have neurological disorders other than Alzheimer's, frontotemporal dementia, vascular dementia, or Lewy body dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CVL-871 or placebo tablets orally once daily up to Day 85

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CVL-871
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: CVL-871 3.0 mg Experimental Treatment 1 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 mg Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Participants will receive a placebo matched to CVL-871 tablets orally QD until Day 85 during the treatment period.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+

Published Research Related to This Trial

In a study involving 371 Alzheimer's patients, symptom improvement trajectories were similar for both placebo and active drug responders, indicating that the type of treatment may not significantly affect the pattern of symptom relief.

A 10% improvement in symptoms by week 2 was found to be the best predictor of a placebo response by week 8, suggesting that early improvements can help identify patients who may benefit from treatment and reduce trial failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo Effects in the Treatment of Noncognitive Symptoms of Alzheimer's Disease: Analysis of the CATIE-AD Data. Ozawa, C., Roberts, R., Yoshida, K., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04958031?rank=1

Study Details | NCT04958031 | A Trial of the Safety, ... The purpose of this study is to determine whether CVL-871 is safe and tolerable in patients with Dementia-Related Apathy and if CVL-871 shows changes in ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=CVL-871-2001

CVL-871-2001 The purpose of this study is to determine whether CVL-871 is safe and tolerable in patients with Dementia-Related Apathy and if CVL-871 shows changes in ...

3. withpower.com withpower.com/trial/phase-3-dementia-5-2021-7eb99

CVL-871 for Dementia-related Apathy · Info for Participants 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.

4. trialx.com trialx.com/clinical-trials/listings/260718/a-trial-of-the-safety-tolerability-and-pharmacodynamics-of-cvl-871-in-subjects-with-dementia-related-apathy/

A Trial of the Safety, Tolerability, and Pharmacodynamics ... The purpose of this study is to determine whether CVL-871 is safe and tolerable in patients with Dementia-Related Apathy and if CVL-871 shows changes in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10366907/

An Update on Apathy in Alzheimer's Disease - PubMed Central In a study published in 2023, individuals with dementia experiencing apathy showed impaired learning in social and monetary reward conditions, ...