Phase
Condition
Dementia
Schizophrenia And Schizoaffective Disorders (Pediatric)
Psychosis
Treatment
KarXT
KarX-EC
KarXT + KarX-EC Arm Matching Placebo
Clinical Study ID
Ages 55-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
Participants must be diagnosed with Alzheimer's disease in accordance with the 2024revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer'sAssociation Workgroup.
Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during orsubsequent 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.
Participants must have a history of psychotic symptoms (meeting InternationalPsychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).
Exclusion
Exclusion Criteria:
Participants must not have psychotic symptoms that are primarily attributable to acondition other than the AD causing the dementia, eg, schizophrenia, schizoaffectivedisorder, delusional disorder, or mood disorder with psychotic features.
Participants must not have history of major depressive episode with psychoticfeatures during the 12 months prior to Screening, or history of bipolar disorder,schizophrenia, or schizoaffective disorder.
Participants must not have certain safety concerns, including certain laboratorytest irregularities.
Other protocol-defined Inclusion/Exclusion criteria apply.
Study Design
Connect with a study center
Local Institution - 0020
Macquarie Park, New South Wales 2113
AustraliaSite Not Available
Local Institution - 0052
Nedlands, Western Australia 6009
AustraliaSite Not Available
Local Institution - 0054
Toronto, Ontario M6J1H4
CanadaSite Not Available
Local Institution - 0027
Whitby, Ontario L1N 5S9
CanadaSite Not Available
Local Institution - 0025
Montreal, Quebec H4H 1R3
CanadaSite Not Available
Local Institution - 0040
Suita, Osaka 565-0871
JapanSite Not Available
Local Institution - 0035
Nankoku-shi, 783-8505
JapanSite Not Available
Local Institution - 0034
Osaka, 550-0006
JapanSite Not Available
Local Institution - 0005
Exeter, Devon EX12LU
United KingdomSite Not Available
Local Institution - 0018
Saint Leonards-on-Sea, East Sussex TN61HB
United KingdomSite Not Available
Local Institution - 0023
London, England W1G 8TA
United KingdomSite Not Available
Local Institution - 0015
Oxford, Oxfordshire OX3 7JX
United KingdomSite Not Available
Local Institution - 0009
Chertsey, Surrey KT160PZ
United KingdomSite Not Available
Local Institution - 0017
Sheffield, Yorkshire and the Humber S47QQ
United KingdomSite Not Available
Local Institution - 0024
London, WC1N3BG
United KingdomSite Not Available
Local Institution - 0004
Motherwell, ML1 4UF
United KingdomSite Not Available
Local Institution - 0042
Gilbert, Arizona 85297
United StatesSite Not Available
Inland Psychiatric Medical Group.
Chino, California 91710
United StatesActive - Recruiting
Local Institution - 0001
Naples, Florida 34105
United StatesSite Not Available
Local Institution - 1401
Naples, Florida 34105
United StatesSite Not Available
Local Institution - 0029
Cleveland, Ohio 44195
United StatesSite Not Available
Local Institution - 0043
Shaker Heights, Ohio 44122-5288
United StatesSite Not Available

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