Emraclidine for Elderly Healthy Subjects

No longer recruiting at 8 trial locations

Overseen By Cerevel Clinical Trial Support

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cerevel Therapeutics, LLC

Must be taking: Cholinesterase inhibitors, Memantine

Disqualifiers: Substance use disorder, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called emraclidine to assess its safety and tolerability. Part A involves healthy elderly individuals receiving different doses to determine the optimal amount. Part B focuses on individuals with dementia due to Alzheimer's disease to evaluate emraclidine's effects. Suitable candidates for Part B include those with Alzheimer's who have been on stable dementia treatments and are willing to continue them during the trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are in Cohort 6 (Part B) and are receiving oral symptomatic treatment for dementia, you must have been on a stable dose for at least 6 weeks before the trial and be willing to maintain that dose during the trial.

Is there any evidence suggesting that emraclidine is likely to be safe for humans?

Research has shown that emraclidine has undergone safety testing in several studies. In trials with healthy older adults, emraclidine was generally well-tolerated. Some participants experienced mild to moderate side effects, such as headaches or dizziness, but these were not serious. Another study involving individuals with schizophrenia showed similar results, indicating that emraclidine is safe for long-term use with manageable side effects.

Since this trial is in the early stages, the main goal is to assess safety and tolerability. Researchers are closely monitoring for any negative effects. If emraclidine receives approval for other uses in the future, it will likely be based on these safety findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about emraclidine because it offers a new approach to treating conditions like dementia due to Alzheimer's disease. Unlike standard treatments that often focus on managing symptoms or slowing progression through neurotransmitter pathways, emraclidine targets the muscarinic acetylcholine receptors, which are believed to play a key role in cognitive function. This unique mechanism of action could potentially offer improved cognitive benefits and symptom relief, setting it apart from current options. Additionally, emraclidine is administered orally, which may enhance patient compliance and convenience compared to other treatment forms.

What evidence suggests that emraclidine might be an effective treatment for Alzheimer's disease?

Research has shown that emraclidine may help treat certain conditions by affecting brain areas related to mood and thinking. In earlier studies, emraclidine was tested for its ability to help with schizophrenia symptoms, and participants showed improved thinking skills. This suggests it might also help with conditions like Alzheimer's disease, which impacts brain function. Early trials found that emraclidine was generally safe for older adults, an important factor in treating dementia. While more research is needed, these early results suggest that emraclidine could be effective for Alzheimer's-related dementia. Participants in this trial will receive different doses of emraclidine or a placebo to further evaluate its safety and potential benefits. ^{1 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for elderly individuals in good health, confirmed by medical checks. Participants must not have used certain medications recently, including high doses of NSAIDs or anticholinergic agents. They should have a BMI between 17.5 and 32 kg/m2 and weigh over 45 kg (100 lbs). Women must be postmenopausal or sterilized; men are also eligible. No prior participation in emraclidine trials.

Inclusion Criteria

I am willing to sign an informed consent and follow study rules.

I am a male, or I am a female who cannot have children due to menopause or surgery.

Are you in good overall health? This will be confirmed by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results.

Exclusion Criteria

I have been in menopause for at least 12 months, confirmed by a blood test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive multiple ascending doses of emraclidine or placebo, orally, once daily up to Day 14

2 weeks

Treatment Part B

Participants with dementia due to Alzheimer's disease receive emraclidine or placebo, orally, once daily up to Day 28

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Emraclidine
• Placebo

Trial Overview The study tests the safety of multiple oral doses of emraclidine compared to a placebo in older adults. The main goal is to see how well participants tolerate different amounts of this medication when taken more than once.

How Is the Trial Designed?

Group I: Part B: Cohort 6: Emraclidine Dose 6 Experimental Treatment 2 Interventions

Participants with dementia due to AD will receive emraclidine dose 6 or emraclidine-matching placebo tablets, orally, QD up to Day 28.

Group II: Part A: Cohort 5: Emraclidine Dose 5 Experimental Treatment 2 Interventions

Participants will receive emraclidine dose 5 or emraclidine-matching placebo tablets, orally, QD up to Day 14.

Group III: Part A: Cohort 4: Emraclidine Dose 4 Experimental Treatment 2 Interventions

Participants will receive emraclidine dose 4 or emraclidine-matching placebo tablets, orally, QD up to Day 14.

Group IV: Part A: Cohort 3: Emraclidine Dose 3 Experimental Treatment 2 Interventions

Participants will receive emraclidine dose 3 or emraclidine-matching placebo tablets, orally, QD up to Day 14.

Group V: Part A: Cohort 2: Emraclidine Dose 2 Experimental Treatment 2 Interventions

Participants will receive emraclidine dose 2 or emraclidine-matching placebo tablets, orally, QD up to Day 14.

Group VI: Part A: Cohort 1: Emraclidine Dose 1 Experimental Treatment 2 Interventions

Participants will receive emraclidine dose 1 or emraclidine-matching placebo tablets, orally, once daily (QD) up to Day 14.

Who Is Running the Clinical Trial?

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05644977?rank=1

A Multiple Dose Trial of Emraclidine in Elderly Participants ... The primary purpose of the study is to evaluate the safety and tolerability of emraclidine administered orally to healthy elderly participants in Part A ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=CVL-231-1006

A Multiple Dose Trial of Emraclidine in Elderly Participants ... The primary purpose of the study is to evaluate the safety and tolerability of emraclidine administered orally to healthy elderly participants in Part A.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05227690

A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in ... This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability ...

4. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-11-2022-eadae

Emraclidine for Elderly Healthy Subjects · Info for Participants This trial is for elderly individuals in good health, confirmed by medical checks. Participants must not have used certain medications recently, including high ...

5. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=CVL-231-2002

A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in ... This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07219030

NCT07219030 | A Study to Assess the Adverse Events and ... This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05443724

A Study to Evaluate Safety and Tolerability of CVL-231 ... The primary purpose of this study is to assess the long-term safety and tolerability of oral emraclidine in adult participants with schizophrenia.

8. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2022-001151-16/BG

Clinical Trials Register The European Union Clinical Trials Register allows you to search for protocol and results information on EU/EEA interventional clinical trials.

9. adisinsight.springer.com adisinsight.springer.com/trials/700387307

A Phase 1, Randomized, Placebo-controlled Study to ... This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, ...