Emraclidine for Elderly Healthy Subjects

Recruiting at8 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Cerevel Therapeutics, LLC

Must be taking: Cholinesterase inhibitors, Memantine

Disqualifiers: Substance use disorder, Cardiovascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the safety of a drug called emraclidine, which is taken by mouth, in elderly 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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Emraclidine (NMDA receptor antagonist)
• Placebo (Drug)

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.

Participant Groups

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