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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051240245

Registered date:20/01/2025

A Phase 3, Parallel Group Study to Evaluate KarXT as a Treatment for Psychosis Associated with Alzheimer's Disease

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPsychosis Associated with Alzheimer's Disease
Date of first enrollment31/01/2025
Target sample size406
Countries of recruitmentUnited States,Japan,Belgium,Japan,Bulgaria,Japan,Croatia,Japan,Czech Republic,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Poland,Japan,Portugal,Japan,Serbia,Japan,Slovakia,Japan,Spain,Japan,United Kingdom,Japan
Study typeInterventional
Intervention(s)KarXT Arm:Specified dose on specified days Placebo:Specified dose on specified days

Outcome(s)

Primary OutcomeChange from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score. (Up to Week 14)
Secondary Outcome- Change from baseline in Cohen- Mansfield Agitation Inventory (CMAI) total score. (Up to Week 14) - Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale. (Up to Week 14) - Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain. (Up to Week 14) - Change from baseline in NPI-C Core score: Delusion Domain. (Up to Week 14) - Change from baseline in NPI-C Core score: Agitation Domain. (Up to Week 14) - Change from baseline in NPI-C Core score: Aggression Domain. (Up to Week 14) - Change from baseline in NPI-C Agitation score. (Up to Week 14) - Change from baseline in NPI-C Core score: Caregiver Distress Scale. (Up to Week 14) - Number of participants with a >= 40% improvement from Baseline in NPI-C: H+D score. (Up to Week 14) - Number of participants with Adverse Events (AEs). (Up to Week 14) - Number of participants with Treatment-Emergent Adverse Events (TEAEs). (Up to Week 14) - Number of participants with Serious Adverse Events (SAEs). (Up to Week 14) - Number of participants with TEAEs leading to study withdrawal. (Up to Week 14) - Number of participants with procholinergic symptoms. (Up to Week 14) - Number of participants with anticholinergic symptoms. (Up to Week 14) - Number of participants with AEs of Special Interest (AESIs). (Up to Week 14) - Barnes Akathisia Rating Scale (BARS) Score. (Up to Week 14) - Abnormal Involuntary Movement Scale (AIMS) Score. (Up to Week 14) - Body Weight. (Up to Week 14) - Body Mass Index (BMI). (Up to Week 14) - Number of participants with vital sign abnormalities. (Up to Week 14) - Number of participants with clinical laboratory abnormalities. (Up to Week 14) - Number of participants with 12-lead electrocardiogram (ECG) abnormalities. (Up to Week 14) - Number of participants with suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). (Up to Week 14) - Cognition as assessed by the Mini-Mental State Examination (MMSE). (Up to Week 14) - Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13). (Up to Week 14)

Key inclusion & exclusion criteria

Age minimum>= 55age old
Age maximum<= 90age old
GenderBoth
Include criteria-Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). -Patients who are diagnosed with possible AD or probable AD (refer to the appendix for the National Institute on Aging - Alzheimer's Association Guidelines for All-cause Dementia and Alzheimer's Disease). -Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma. -Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
Exclude criteria-Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. -History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. -Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.

Related Information

Contact

Public contact
Name Ronald Marcus
Address 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004
Telephone +81-120-093-507
E-mail MG-JP-RCO-JRCT@bms.com
Affiliation Bristol-Myers Squibb
Scientific contact
Name Ronald Marcus
Address 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004
Telephone +81-120-093-507
E-mail mg-jp-clinical_trial@bms.com
Affiliation Bristol-Myers Squibb