Study of Emraclidine in Healthy Older Adults
This study is looking for healthy adults aged 65 to 85 to understand how a drug called emraclidine moves through the body and to check for any side effects. You would receive either emraclidine or a placebo (an inactive pill). Researchers will be watching for any adverse events (unwanted or unexpected medical problems), changes in your vital signs (like blood pressure and heart rate), and changes in your heart's electrical activity (measured by an ECG). The study aims to enroll 40 participants, but its current recruitment status is unclear.
- Study design
- This interventional study involves giving participants either emraclidine or a placebo. It plans to enroll 40 healthy elderly adult participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor for adverse events for up to approximately 50 days, and vital signs and ECG changes for up to approximately 20 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
At a glance
Conditions
Where it's being run
4 sites across 3 statesStudy leadership
- ABBVIE INC. · STUDY_DIRECTOR · AbbVie
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of Participants Experiencing Adverse EventsUp to approximately 50 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Number of Participants with Clinical Significant Change From Baseline in Vital Sign MeasurementsUp to approximately 20 days
Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
- Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)Up to approximately 20 days
12-lead resting ECG will be recorded.
- Number of Participants with Clinical Significant Change in Physical ExaminationsUp to approximately 20 days
Number of participants with clinical significant change in physical examinations will be assessed.
- Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be AssessedUp to approximately 20 days
Number of participants with clinical significant change in clinical laboratory test results will be assessed.
- Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)Up to approximately 20 days
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)Up to approximately 20 days
AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.
- Change From Baseline in Barnes Akathisia Rating Scale (BARS)Up to approximately 20 days
BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal \[0\] to severe \[3\]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent \[0\] to severe akathisia \[5\]).
- Change From Baseline in Simpson-Angus Scale (SAS)Up to approximately 20 days
SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.
- Maximum Observed Plasma Concentration (Cmax) of EmraclidineUp to approximately 20 days
Cmax of Emraclidine
- Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)Up to approximately 20 days
Cmax of Metabolite (CV-0000364)
- Time to Cmax (Tmax) of EmraclidineUp to approximately 20 days
Tmax of Emraclidine
- Time to Cmax (Tmax) of Metabolite (CV-0000364)Up to approximately 20 days
Tmax of Metabolite (CV-000036)
- Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of EmraclidineUp to approximately 20 days
AUCt of Emraclidine
- Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)Up to approximately 20 days
AUCt of Metabolite (CV-000036)
- Area under the plasma concentration-time curve over the dosing interval (AUCtau) of EmraclidineUp to approximately 20 days
AUCtau of Emraclidine
- Minimum plasma concentration (Cmin) of EmraclidineUp to approximately 20 days
Cmin of Emraclidine
- Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)Up to approximately 20 days
Cmin of Metabolite (CV-0000364)
- Average plasma concentration (Cavg) of EmraclidineUp to approximately 20 days
Cavg of Emraclidine
- Average plasma concentration (Cavg) of Metabolite (CV-0000364)Up to approximately 20 days
Cavg of Metabolite (CV-0000364)
- Metabolite to Parent Ratio (MRCmax) of EmraclidineUp to approximately 20 days
MRCmax of Emraclidine calculated from Cmax
- Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)Up to approximately 20 days
MRCmax of Metabolite (CV-0000364) calculated from Cmax
- Metabolite to Parent Ratio (MRAUCtau) of EmraclidineUp to approximately 20 days
MRAUCtau of Emraclidine based on AUCtau
- Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)Up to approximately 20 days
MRAUCtau of Metabolite (CV-000036) based on AUCtau
- Terminal Phase Elimination Half-Life (t1/2) of EmraclidineUp to approximately 20 days
Terminal phase elimination half-life of Emraclidine
- Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036)Up to approximately 20 days
Terminal phase elimination half-life of Metabolite (CV-000036)
- Apparent terminal phase elimination constant (β) of EmraclidineUp to approximately 20 days
β of Emraclidine
- Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)Up to approximately 20 days
β of Metabolite (CV-0000364)
- Peak-to-trough ratio (PTR) of EmraclidineUp to approximately 20 days
PTR of Emraclidine
- Peak-to-trough ratio (PTR) of Metabolite (CV-000036)Up to approximately 20 days
PTR of Metabolite (CV-000036)
- Accumulation ratio for Cmax (RacCmax) of EmraclidineUp to approximately 20 days
RacCmax of Emraclidine
- Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)Up to approximately 20 days
RacCmax of Metabolite (CV-0000364)
- Accumulation ratio for AUCtau (RacAUCtau) of EmraclidineUp to approximately 20 days
RacAUCtau of Emraclidine
- Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)Up to approximately 20 days
RacAUCtau of Metabolite (CV-0000364)
- Apparent Clearance of Drug from Plasma (CL/F) of EmraclidineUp to approximately 20 days
CL/F of Emraclidine
- Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of EmraclidineUp to approximately 20 days
Vz/F of Emraclidine
- Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364)Up to approximately 20 days
AUCtau of Metabolite (CV-0000364)