Phase
Condition
Dementia
Treatment
Emraclidine
Placebo
Clinical Study ID
Ages 55-90 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Cohorts 1 to 5 (Part A)
Male participants and female participants of nonchildbearing potential, ages 65 to 85 years, inclusive.
Healthy as determined by medical evaluation, including medical and psychiatrichistory, physical and neurological examinations, ECG, vital sign measurements, andlaboratory test results, as evaluated by the investigator.
Body mass index of 17.5 to 32.0 kilograms per square meter (kg/m^2), inclusive, andtotal body weight >45 kg (100 pounds [lb]) at Screening.
Female participants will be of nonchildbearing potential, defined as follows:
• Achieved postmenopausal status, defined as follows: cessation of regular mensesfor at least 12 consecutive months with no alternative pathological or physiologicalcause, and confirmed with a serum follicle-stimulating hormone level >40international units per milliliter (IU/mL).
- Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in thefull protocol.
Cohort 6 (Part B)
Male participants and female participants of nonchildbearing potential, ages 55 to 90 years, inclusive.
Have a clinical diagnosis of possible or probable Alzheimer's disease dementiaaccording to the 2011 National Institute on Aging - Alzheimer's Association (NIA-AA)clinical criteria at the Screening Visit; diagnosis must be stable for at least 6months prior to signing the ICF.
Have a Mini-Mental State Examination (MMSE) score of 8 through 26, inclusive, at theScreening Visit.
Have prior neuroimaging evidence (Computed Tomography [CT] or Magnetic resonanceimaging [MRI] completed within the 3 years prior to signing the ICF) collectedduring or subsequent to the onset of dementia symptoms to rule out other centralnervous system disorders that could account for the dementia syndrome.
Currently receiving oral symptomatic treatment for dementia (i.e., cholinesteraseinhibitor and/or memantine), must have been on a stable regimen for at least 6 weeksprior to signing ICF and be willing to maintain a stable dose for the duration ofthe trial.
Body mass index of 17.5 to 40.0 kg/m2, inclusive, and total body weight >45 kg (100lb) at Screening.
Exclusion
Exclusion Criteria:
All Cohorts
- "Yes" responses for any of the following items on the C-SSRS (within the past 6months):
Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act,without Specific Plan)
Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan andIntent) "Yes" responses for any of the following items on the C-SSRS (withinpast 2 years):
Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt,Aborted Attempt, Preparatory Acts or Behavior). Serious risk of suicide in theopinion of the investigator is also exclusionary.
Diagnosis of moderate to severe substance or alcohol-use disorder (excludingnicotine or caffeine) as per Diagnostic and Statistical Manual of Mental Disorders,Fifth Edition (DSM-5) criteria within 12 months prior to signing the ICF.
Positive drug screen or a positive test for alcohol at Screening or Baseline Visits.
Any of the following clinical laboratory test results at the Screening Visit (asassessed by the central laboratory) and at Check-in (Day -1; as assessed by thelocal laboratory), and confirmed by a single repeat measurement, if deemednecessary:
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.0 × upperlimit normal (ULN)
Total bilirubin >1.5 × ULN. If Gilbert's syndrome is suspected, total bilirubin >1.5 × ULN is acceptable if the conjugated or direct bilirubin fraction is <20%of total bilirubin.
Cohorts 1 to 5 (Part A)
Current or past history of significant pulmonary, gastrointestinal, renal, hepatic,metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at thediscretion of the investigator), hematological, immunological, neurological, orpsychiatric disease that, in the opinion of the investigator or medical monitor,could compromise either participant safety or the results of the trial.
Current or past history of significant cardiovascular disease.
Estimated glomerular filtration rate <60 milliliters per minute (mL/min)/1.73 m^2,as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI
- equation at the Screening Visit or Check-in (Day -1).
Cohort 6 (Part B)
- Has either of the following:
History of major depressive episode with psychotic features during the 12months prior to signing the ICF
History of a diagnosis of bipolar disorder, schizophrenia, or schizoaffectivedisorder
- Has evidence of a clinically relevant neurological disorder other than possible orprobable Alzheimer's disease such as, but not limited to, the following:
History of ischemic stroke within 12 months prior to signing the ICF or anyevidence of hemorrhagic stroke
History of cerebral amyloid angiopathy, epilepsy, or central nervous systemneoplasm
- Estimated glomerular filtration rate <60 mL/min/1.73 m2, as calculated using theCKD-EPI 2021 equation the Screening Visit.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Connect with a study center
Cypress, California
Cypress, California 90630
United StatesSite Not Available
San Diego, California
San Diego, California 92103
United StatesSite Not Available
Hialeah, Florida
Hialeah, Florida 33014
United StatesSite Not Available
Decatur, Georgia
Decatur, Georgia 30030
United StatesSite Not Available
Honolulu, Hawaii
Honolulu, Hawaii 96817
United StatesSite Not Available
Overland Park, Kansas
Overland Park, Kansas 66212
United StatesSite Not Available
Farmington Hills, Michigan
Farmington Hills, Michigan 48334
United StatesSite Not Available
Marlton, New Jersey
Marlton, New Jersey 08053
United StatesSite Not Available
Princeton, New Jersey
Princeton, New Jersey 08540
United StatesSite Not Available
Staten Island, New York
Staten Island, New York 10314
United StatesSite Not Available
North Canton, Ohio
North Canton, Ohio 44720
United StatesSite Not Available
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