The primary purpose of the study is to evaluate the safety and tolerability of emraclidine administered orally to healthy elderly participants in Part A (multiple ascending doses) and participants with dementia due to Alzheimer's disease (AD) in Part B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
Oral tablets
Oral tablets
Cypress, California
Cypress, California, United States
San Diego, California
San Diego, California, United States
Hialeah, Florida
Hialeah, Florida, United States
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 28
Part A: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to Day 17
Part A: Number of Participants With Clinically Significant Changes in Laboratory Assessments
Time frame: Up to Day 17
Part A: Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Time frame: Up to Day 17
Part A: Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Up to Day 17
Part A: Changes in Suicidality Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Time frame: Up to Day 17
Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Simpson Angus Scale (SAS)
The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items.
Time frame: Up to Day 14
Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Decatur, Georgia
Decatur, Georgia, United States
Honolulu, Hawaii
Honolulu, Hawaii, United States
Overland Park, Kansas
Overland Park, Kansas, United States
Farmington Hills, Michigan
Farmington Hills, Michigan, United States
Marlton, New Jersey
Marlton, New Jersey, United States
Princeton, New Jersey
Princeton, New Jersey, United States
Staten Island, New York
Staten Island, New York, United States
...and 1 more locations
The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status.
Time frame: Up to Day 14
Part A: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms Evaluated Using the Barnes Akathisia Rating Scale (BARS)
The BARS consists of 4 items related to akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia.
Time frame: Up to Day 14
Part B: Number of Participants With TEAEs, Clinically Significant Changes in ECG Parameters, Laboratory Assessments, Vital Sign Measurements, and Physical and Neurological Examination Results
Time frame: Up to Day 28
Part B: Changes in Suicidality Assessed Using the C-SSRS
Time frame: Up to Day 28
Part B: Number of Participants With Clinically Significant Findings in Extrapyramidal Symptoms
Extrapyramidal symptoms will be evaluated using SAS, AIMS, and BARS scales.
Time frame: Up to Day 28
Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
Time frame: Days 1 and 14
Part A: Time to Maximum Plasma Concentration (Tmax) of Emraclidine and its Metabolite CV-0000364
Time frame: Days 1 and 14
Part A: Area Under the Plasma Concentration-time Curve (AUC) of Emraclidine and its Metabolite CV-0000364
Time frame: Days 1 and 14
Part A: Trough Plasma Concentration (Ctrough) of Emraclidine and its Metabolite CV-0000364
Time frame: Days 1 and 14
Part A: Peak to Trough Ratio (PTR) of Emraclidine and its Metabolite CV-0000364
Time frame: Day 14
Part A: Apparent Clearance of Drug From Plasma (CL/F) of Emraclidine
Time frame: Days 1 and 14
Part A: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Emraclidine
Time frame: Days 1 and 14
Part A: Apparent Terminal Half-life (t1/2) of Emraclidine and its Metabolite CV-0000364
Time frame: Days 1 and 14
Part A: Accumulation Ratio (Rac) of Emraclidine and its Metabolite CV-0000364
Rac would be calculated from AUC and Cmax of emraclidine and its metabolite.
Time frame: Day 14
Part A: Metabolite to Parent Ratio of Emraclidine and its Metabolite CV-0000364
Time frame: Days 1 and 14
Part B: Plasma Concentrations of Emraclidine and its Metabolite CV-0000364
Time frame: Days 1 to 28