Table of Contents
- Trial overview
- Conditions being studied
- How the trials are designed
- What the trials measure
- Who can participate
- Trial status and size
- Key points for patients
Trial overview
The listed studies are all Phase 3 trials, which means they are testing Xanomeline Tartrate in larger groups to learn more about benefit and safety.[1] Most of the studies are interventional, meaning researchers give a study treatment and compare results with placebo or another study group.[1]
The trials focus on several brain and mental health conditions, including schizophrenia, bipolar I mania, agitation related to Alzheimer’s disease, psychosis related to Alzheimer’s disease, and mild to moderate Alzheimer’s disease with cognitive impairment.[1]
Conditions being studied
Schizophrenia is being studied in adults and also in adolescents aged 13 to 17 years.[1] One schizophrenia study is for people with inadequately controlled symptoms, and another is a rollover study that follows people who finished an earlier trial.[1]
Bipolar-I disorder studies focus on manic episodes, including mania with mixed features, which means mania together with some depression symptoms.[1] One study looks at people taking lithium, valproate, or lamotrigine, which are mood-stabilizing medicines already used for bipolar disorder.[1]
Several studies also look at Alzheimer’s disease-related symptoms, including agitation, psychosis, and cognitive impairment in mild to moderate disease.[1] Agitation means restlessness or distress, while psychosis means symptoms such as hallucinations or delusions.[1]
How the trials are designed
Some studies compare Xanomeline Tartrate with placebo, which is a dummy treatment with no active medicine.[1] This helps researchers see whether changes are likely due to the study treatment rather than chance.[1]
Several trials test Xanomeline Tartrate as a single treatment, while others test it as an add-on treatment.[1] The Alzheimer’s disease agitation studies and the bipolar I mania study with mood stabilizers are examples of add-on or combination research.[1]
There are also open-label extension studies, which means participants and researchers know what treatment is being given and the main goal is to watch long-term safety and tolerability.[1]
What the trials measure
The studies use different rating tools depending on the condition being treated.[1] For schizophrenia, the PANSS total score is used to measure symptom change, and one study in Alzheimer’s disease psychosis uses the NPI-C hallucinations and delusions score.[1]
For mania in bipolar I disorder, the main measure is the YMRS, which tracks manic symptoms.[1] For agitation in Alzheimer’s disease, the trials use the CMAI-IPA total score to measure change in agitation.[1]
The cognitive impairment studies in Alzheimer’s disease use ADAS-Cog11 for thinking skills and CIBIC+ for global functioning, which means the person’s overall condition and day-to-day change.[1] Long-term safety studies mainly track treatment-emergent adverse events, which are side effects or medical problems that appear after treatment starts.[1]
Who can participate
Based on the trial data, the main groups are adults with schizophrenia, adults with bipolar I disorder, and adults with Alzheimer’s disease-related symptoms.[1] One study also includes adolescents aged 13 to 17 years with schizophrenia.[1]
Some studies are limited to people with a specific symptom pattern, such as mania with mixed features or psychosis associated with Alzheimer’s disease.[1] Other studies include people who have already completed a previous trial or those already taking mood stabilizers for bipolar I disorder.[1]
Trial status and size
Most of the listed trials are Authorised, which means they are approved to run in the source data provided.[1] Two schizophrenia studies are marked Completed, and one study in schizophrenia is marked Withdrawn.[1]
The enrollment numbers range from 166 participants in the adolescent schizophrenia study to 602 participants in the open-label extension study for agitation in Alzheimer’s disease.[1] These larger numbers help researchers collect more information about both benefit and safety over time.[1]
Key points for patients
Most studies are trying to see whether Xanomeline Tartrate improves symptoms better than placebo.[1]
The main conditions are schizophrenia, bipolar I mania, and Alzheimer’s disease-related agitation, psychosis, and cognitive impairment.[1]
Some studies look at short-term symptom change, while others focus on long-term safety and tolerability.[1]
Different rating scales are used depending on the condition, such as PANSS, YMRS, CMAI-IPA, NPI-C, ADAS-Cog11, and CIBIC+.[1]
The studies include adults, and one trial includes teenagers with schizophrenia.[1]
