Emraclidine in Healthy Elderly Adults

Recruiting at 4 trial locations

Overseen By ABBVIE CALL CENTER

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Cardiac, Respiratory, Renal, Hepatic, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2-3 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the drug emraclidine moves through the bodies of healthy, older adults and checks for any side effects. Participants will take either emraclidine or a placebo (a harmless pill with no active drug) for 10 or 17 days. As a Phase 1 trial, it primarily focuses on safety and how well the body tolerates the drug. Suitable candidates for this trial are individuals in good general health without significant medical issues. Participants have the opportunity to be among the first to receive this new treatment and contribute to understanding its effects in people.

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 shows that emraclidine is under study for its safety in healthy older adults. Previous studies have examined its tolerability and potential side effects. Although emraclidine remains in early testing, its presence in a Phase 1 trial indicates a focus on safety.

In earlier studies, researchers administered emraclidine to older participants and observed their bodily responses. These studies aim to confirm that emraclidine is safe and well-tolerated in multiple doses. However, as the research is still in early stages, more information is needed to fully understand its safety. Participants in these trials receive close monitoring for any unwanted side effects to ensure the treatment's safety for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about emraclidine because it offers a fresh approach to treating conditions that primarily affect the elderly, potentially improving cognitive function. Unlike many current treatments that focus on symptom management, emraclidine targets the muscarinic acetylcholine receptors in the brain, which play a critical role in cognitive processes. This new mechanism of action could lead to more effective results with fewer side effects. Additionally, its oral delivery method makes it easy and convenient for patients to take, which is a significant advantage over treatments that require more complex administration.

What evidence suggests that this trial's treatments could be effective?

Research has shown that emraclidine might positively affect brain receptors related to mental health issues. Early findings suggest it targets a specific brain receptor involved in thinking and mood. Although detailed information on its effectiveness in people is limited, its mechanism offers hope for symptom relief in these areas. In this trial, participants will receive either emraclidine or a placebo to assess its safety and tolerability, crucial steps before evaluating its efficacy. This treatment remains in the early research stages, so further information is needed to confirm its benefits. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for healthy elderly adults who meet specific health criteria. The exact inclusion and exclusion details are not provided, but typically participants must pass a medical screening to ensure they don't have conditions that could affect the study's safety or results.

Inclusion Criteria

BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters

A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

I weigh more than 45 kg.

Exclusion Criteria

I have had cancer or precancerous conditions, except for certain skin cancers or early-stage cervical cancer.

I do not have any significant ongoing health issues.

History of any clinically significant sensitivity or allergy to any medication or food

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral doses of emraclidine or placebo for 10 to 17 days

2-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Emraclidine

Trial Overview The study is testing how emraclidine, taken orally, moves through the bodies of healthy elderly individuals. It also looks at what side effects occur and how well these participants can tolerate the drug compared to a placebo.

How Is the Trial Designed?

Group I: Emraclidine or Placebo- Group 4 Experimental Treatment 2 Interventions

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.

Group II: Emraclidine or Placebo- Group 3 Experimental Treatment 2 Interventions

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.

Group III: Emraclidine or Placebo- Group 2 Experimental Treatment 2 Interventions

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days

Group IV: Emraclidine or Placebo- Group 1 Experimental Treatment 2 Interventions

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days

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

Citations

1. 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 ...

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. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2025-63aa8

Emraclidine in Healthy Elderly Adults This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability. Show ...

4. 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 ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/35744819/abbvie-advances-with-emraclidine-study-in-elderly-a-potential-game-changer/

AbbVie Advances with Emraclidine Study in Elderly ' The study aims to assess how the drug emraclidine moves through the body and its safety and tolerability in healthy elderly participants. This ...

6. clinicaltrials.eu clinicaltrials.eu/inn/emraclidine/

Emraclidine – Application in Therapy and Current Clinical ... Elderly Individuals: The effects and safety of Emraclidine in older adults are being specifically studied. Alzheimer's Disease Patients: The same study ...

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

Emraclidine for Elderly Healthy Subjects · Info for Participants 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 ...