Trospium chloride; Xanomeline tartrate for Psychosis associated with Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- •\tPatients who are 55-90 years old"}
• {"criterion_text":"- • Diagnosed with AD based on the 2024 National Institute on Aging – Alzheimer’s Association criteria with AD biomarker confirmation"}
• {"criterion_text":"- •\tParticipants who 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"}
• {"criterion_text":"- •\tPatient 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)"}

Exclusion criteria

• {"criterion_text":"- •\tPatients will not be able to participate if they have 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."}
• {"criterion_text":"- •\tHistory of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder."}
• {"criterion_text":"- •\tPatients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities."}

Primary endpoints

• {"endpoint_text":"- The main endpoint is the change from Baseline to End of Treatment in NPI-C: H+D score.","definition_or_measurement_approach":"Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score."}

Secondary endpoints

• {"endpoint_text":"- The key secondary endpoint is the change from Baseline to End of Treatment on CGI-S score.","definition_or_measurement_approach":"Change from Baseline to End of Treatment on the Clinical Global Impression - Severity (CGI-S) scale; assessor provides a global assessment of severity considering psychosis aspects (hallucinations and delusions)."}

Methods

• Digital marketing and online recruitment (Trialbee digital marketing content, Trialbee landing pages, Trialbee self-assessment and secondary assessment communication).
• Print and on-site materials: posters, postcards, patient letters, flip charts, patient-caregiver brochures.
• Vendor/platform-supported recruitment: Elligo (digital/site recruitment), Study Connect and other vendor materials referenced in country recruitment packs.
• Site-based recruitment: physician letters and investigator-site outreach (country-specific K1/K2 materials and physician letters).
• Country-specific recruitment packages: dedicated recruitment arrangements and translated materials for multiple countries (examples: BE, FR, DE, PL, RO, SK, HR, HU, IT, PT, ES, GR, etc.).

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Pharmaceutical Product Development LLC

Responsibilities

Ops for project & site management; medical monitoring, pharmacovigilance, lab, non-IP clinical supplies

Name

PPD Global Ltd.

Responsibilities

Monitoring/regulatory

Name

Catalyst Clinical Research LLC

Responsibilities

Oversight monitoring

Third parties

• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Ops for project & site mngmnt; medical monitoring, pharmacovigilance, lab, non-IP clinical supplies (plus additional sponsor duties listed)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"PK analysis lab","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient travel and reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Elligo Health Research Inc.","duties_or_roles":"Patient recruitment materials development; clinical study branding","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac safety management and ECG shipment","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Data/operational support (sponsor duties code 3)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central Lab and sample management","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Investigator Meeting Planning Services","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Clinical data capture / eClinical services (code 6)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"Hepatitis D and E testing (EU and APAC)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Japan","full_name":"Labcorp Development Japan K.K.","duties_or_roles":"Kit build & distribution; storage & distribution of screening plasma pTau217/Aβ42 ratio & Aβ42/40 (csf) samples for analysis","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Monitoring/regulatory","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long-term sample storage for Study samples","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA and COA assessment: set up, operations and management","organisation_type":"Pharmaceutical company"}
• {"country":"Singapore","full_name":"Azenta Singapore Pte Ltd","duties_or_roles":"Long-term sample storage for Study samples","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long-term sample storage for Study samples","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Quanterix Corp.","duties_or_roles":"Biomarker analysis lab","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Aβ42/40 (csf) analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Catalyst Clinical Research LLC","duties_or_roles":"Oversight monitoring","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Screening plasma pTau217/Aβ42 ratio & Aβ42/40 (csf) analysis, lab kit build and distribution","organisation_type":"Pharmaceutical company"}
• {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"Storage & distribution of screening plasma pTau217/Aβ42 ratio & Aβ42/40 (csf) samples to US for analysis","organisation_type":"Pharmaceutical company"}