What side effects are associated with this type of intervention?

Common treatments similar to Emraclidine, such as other muscarinic receptor modulators, often have side effects related to their anticholinergic properties. These can include dry mouth, constipation, urinary retention, blurred vision, and cognitive disturbances. In clinical trials, these side effects are generally infrequent and mild, but they can vary depending on the specific medication and dosage used.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments in healthy subjects that are directly comparable to Emraclidine, a selective muscarinic M4 receptor positive allosteric modulator. However, muscarinic agonists have been studied for their effects on cognition and other central nervous system functions. For example, partial M1/M3 agonists like AF 102B and L-689,660 have been investigated for their potential therapeutic benefits in cognitive disorders, although their peripheral toxicity has been a concern. These studies highlight the ongoing interest in targeting muscarinic receptors for therapeutic purposes.

What other types of research exist?

Promising novel alternatives to Emraclidine for healthy subjects in 2024 may include other selective muscarinic receptor modulators or treatments targeting similar neurological pathways. Consulting with a healthcare provider for the latest clinical trial data and emerging therapies is recommended.

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NMDA receptor antagonist

Emraclidine for Elderly Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Cerevel Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Is your body mass index between 17.5 to 32.0 kilograms per square meter and is your total body weight >45 kg (100 lbs)?

Timeline

Screening 28 days

Treatment Varies

Follow Up 1 day

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, the trial aims to identify any adverse reactions from taking multiple doses of emraclidine among elderly patients, which could range from mild discomforts like nausea to more serious issues depending on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 17.5 and 32, and I weigh more than 100 lbs.

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

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You have never taken part in a study that looked at emraclidine before.

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

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I haven't taken certain pain or allergy medications above specific doses in the past week.

Timeline

Screening ~ 28 days1 visit

Treatment ~ Varies

Follow Up ~ 1 day0 visits

Screening ~ 28 days

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 28 days for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part A: Changes in Suicidality Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)

Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Barnes Akathisia Rating Scale (BARS)

+2 more

Secondary study objectives

Part A: Accumulation Ratio (Rac) of Emraclidine and its Metabolite CV-0000364

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part B: Cohort 6: Emraclidine Dose 6Experimental Treatment2 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 5Experimental Treatment2 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 4Experimental Treatment2 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 3Experimental Treatment2 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 2Experimental Treatment2 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 1Experimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emraclidine

2024

Completed Phase 1

~110

Placebo

1995

Completed Phase 3

~2670

0 / 6Eligibility 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

Emraclidine, a selective muscarinic M4 receptor positive allosteric modulator, enhances the activity of the M4 receptor, which plays a crucial role in modulating neurotransmitter release and cognitive functions. This mechanism is significant for healthy subjects as it can potentially improve cognitive performance and overall brain health without the broad side effects associated with non-selective muscarinic agonists. By targeting specific receptors, treatments like Emraclidine aim to provide therapeutic benefits while minimizing adverse effects, making them a promising option for maintaining cognitive function in healthy individuals.

Comparison of the effects of selective and nonselective muscarinic agonists on cognition and thermoregulation in primates.Structure-activity relationships among methoctramine-related polymethylene tetraamines. Chain-length and substituent effects on M-2 muscarinic receptor blocking activity.