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ACP-204 in Adults With Alzheimer's Disease Psychosis
1074 patients around the world
Available in
Brazil, United States
ACADIA Pharmaceuticals Inc.
2
Research sites
1074
Patients around the world
This study is for people with
Alzheimer disease
Requirements for the patient
To 95 Years
All Gender
Medical requirements
Inclusion criteria
Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting.
Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria.
Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA).
Has either blood-based biomarker or documented evidence indicating amyloid plaque deposition and neuropathologic change consistent with AD.
Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD.
Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association.
MMSE score ≥6 and ≤24.
Psychotic symptoms for at least 2 months.
Lives in a stable place of residence and there are no plans to change living arrangements.
Has a designated study partner/caregiver.
Able to complete all study visits with a study partner/caregiver.
Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable.
Exclusion criteria
Requires treatment with a medication prohibited by the protocol.
Is in hospice and receiving end-of-life palliative care, or has become bedridden.
Requires skilled nursing care.
Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia.
Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope.
Atrial fibrillation.
Symptomatic orthostatic hypotension.
Protocol-defined exclusionary clinical laboratory findings.
Sites
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
Consult
View site
Rua Dr. Ovídio Pires de Campos 785 - Estado de São Paulo 05403-000
View site
Consult
Psicomed Estudios Clínicos
Recruiting
Consult
View site
Calle Talca 861 Oficina 7 Segunda Región Antofagasta - Antofagasta
View site
Consult
See details
Contact us
Contact us
Sponsor
ACADIA Pharmaceuticals Inc.
Conditions
Alzheimer disease
Requirements
To 95 Years
All Gender
Unique study ID
clinicaltrials.gov
NCT06159673
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