Testing Xanomeline/Trospium Chloride with Xanomeline Enteric against a placebo for alzheimer disease

Inclusion

• +\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.
• +ii) If no historical evidence available: A. A plasma biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → will be assessed for eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
• +B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:
• +Amyloid PET.
• +Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
• +Mini-Mental State Examination (MMSE) score of ≤ 24 at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → (Visit 1).
• +Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:
• +i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate in the study.
• +History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
• +AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Visit 2).
• +CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +\- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
• +ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
• +iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
• +\- Prior/Concomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).
• +A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.
• +B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).
• +C. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
• +\- Other protocolProtocolThe detailed plan a study must follow.Read more →-defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteria apply.