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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
Awards & highlights

Study Summary

This trial will test a new medication's safety and tolerability 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Suicidality Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Number of Participants With Clinically Significant Changes in Laboratory Assessments
+6 more
Secondary outcome measures
Accumulation Ratio (Rac) of Emraclidine and its Metabolite CV-0000364
Apparent Clearance of Drug From Plasma (CL/F) of Emraclidine
Apparent Terminal Half-life (t1/2) of Emraclidine and its Metabolite CV-0000364
+7 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: 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 II: 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 III: 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 IV: 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 V: 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
2023
Completed Phase 1
~80
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,665 Total Patients Enrolled

Media Library

Emraclidine (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05644977 — Phase 1
Healthy Subjects Research Study Groups: Cohort 3: Emraclidine Dose 3, Cohort 5: Emraclidine Dose 5, Cohort 2: Emraclidine Dose 2, Cohort 1: Emraclidine Dose 1, Cohort 4: Emraclidine Dose 4
Healthy Subjects Clinical Trial 2023: Emraclidine Highlights & Side Effects. Trial Name: NCT05644977 — Phase 1
Emraclidine (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05644977 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05644977 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people under the age of 30 participate in this trial?

"This medical experiment is recruiting patients aged between 65 and 85 years."

Answered by AI

Has the FDA granted authorization for Cohort 2: Emraclidine Dose 2?

"Due to the limited amount of data available for Cohort 2: Emraclidine Dose 2, our team at Power rated its safety profile a 1 on a scale from 1 to 3."

Answered by AI

Are there any opportunities to join this research endeavor at the present moment?

"Affirmative. Clinicaltrials.gov reveals that this study is currently recruiting participants, having been first published on December 2nd 2022 and edited most recently on the 20th of December 2022. A total of 50 patients need to be recruited from two distinct medical centres."

Answered by AI

How many individuals are being enrolled in this trial?

"Affirmative. The clinical trial registry on clinicialtrials.gov verifies that this medical study, which was published on December 2nd 2022, is still actively recruiting individuals for participation. About 50 patients need to be enrolled from two different research centres."

Answered by AI

Do I fit the criteria for inclusion in this research protocol?

"This trial is recruiting 50 individuals between the ages of 65 and 85 who meet a strict set of health criteria. Notably, these include being post-menopausal; possessing a body mass index from 17.5 to 32 kg/m^2 with total body weight higher than 45kg (100 lbs); medically cleared; capable of providing informed consent which includes following protocol requirements outlined in the ICF and full protocol."

Answered by AI

Who else is applying?

What state do they live in?
Other
Missouri
Kansas
California
What site did they apply to?
Other
Marlton, New Jersey
Cypress, California
Overland Park, Kansas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2
1
0

Why did patients apply to this trial?

For the money. I want to help. I am just interested. Family hx Alzheimer’s.
PatientReceived 1 prior treatment
Need help with memory.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What is it for? What is it about? What is the study for? What is this study for?
PatientReceived no prior treatments
Yes - what is it about?
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Cypress, California: < 24 hours
  2. Overland Park, Kansas: < 24 hours
Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Multiple Ascending Dose Trial of Emraclidine in Elderly Participants
2022. "A Multiple Ascending Dose Trial of Emraclidine in Elderly Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05644977.
~8 spots leftby Aug 2024
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