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A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease.
EU CTIS ID: 2025-520612-34-00
What this study is testing
To demonstrate the efficacy of KarXT + KarX-EC compared with placebo in the treatment of participants with agitation associated with AD as measured by the Cohen-Mansfield Agitation Inventory – International Psychogeriatric Association (CMAI-IPA) scale.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A diagnosis of Alzheimer’s disease (AD) in accordance with the 2024 Alzheimer’s Association criteria with one of the the following confirmations of AD pathology: - 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. - If no historical evidence available: A. A plasma biomarker will be assessed for eligibility 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: o Amyloid PET o Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay
- Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1)
- Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to: - Attend all visits and report on participant’s status - Oversee participant compliance with medication and study procedures - Participate in the study assessments and provide IC 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 Baseline (Visit 4).
- CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 4)
You likely can't join if
- Medical Conditions Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia History of bipolar disorder, schizophrenia, or schizoaffective disorder History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator Risk of suicidal behavior during the study as determined by the Investigator’s clinical assessment and/or C-SSR
- Prior/Concomitant Therapy - 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) 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 Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1)
- Other protocol-defined Inclusion/Exclusion criteria apply.
See the full eligibility criteria
Who can join
- A diagnosis of Alzheimer’s disease (AD) in accordance with the 2024 Alzheimer’s Association criteria with one of the the following confirmations of AD pathology: - 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. - If no historical evidence available: A. A plasma biomarker will be assessed for eligibility 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: o Amyloid PET o Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay
- Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1)
- Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to: - Attend all visits and report on participant’s status - Oversee participant compliance with medication and study procedures - Participate in the study assessments and provide IC 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 Baseline (Visit 4).
- CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 4)
- At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 4; CMAI-IPA Physical/Verbal Aggression Positivity): - 1 or more aggressive behaviors occurring several times per week - 2 or more aggressive behaviors occurring once or twice per week - 3 or more aggressive behaviors occurring less than once per week
What rules you out
- Medical Conditions Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia History of bipolar disorder, schizophrenia, or schizoaffective disorder History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator Risk of suicidal behavior during the study as determined by the Investigator’s clinical assessment and/or C-SSR
- Prior/Concomitant Therapy - 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) 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 Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1)
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Democratic People's Republic of
- Argentina
- Ukraine
- United Kingdom
- Israel
- United States
- Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Democratic People's Republic of; Argentina; Ukraine; United Kingdom; Israel; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.