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 Several studies are authorised, while some have been completed or withdrawn.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