Study of xanomeline tartrate and trospium chloride combination for treating agitation in Alzheimer’s disease patients

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What is this study about?

This clinical trial aims to test the effectiveness of medications called KarXT and KarX-EC in treating agitation in people with Alzheimer’s Disease. Agitation is a common symptom in Alzheimer’s Disease that includes restlessness, emotional distress, and aggressive behavior. The medications being studied contain active substances called xanomeline tartrate and trospium chloride, which are taken as capsules by mouth.

The study will compare these medications to placebo to see if they can help reduce agitation symptoms in people with Alzheimer’s Disease. During the study, participants will be randomly assigned to receive either the study medications or placebo. Neither the participants nor their doctors will know which treatment they are receiving.

The main way of measuring if the treatment works will be through a special rating scale that measures agitation behaviors. Throughout the study, participants will need to have a caregiver who spends at least 10 hours per week with them to help monitor their condition and assist with taking the medication correctly.

1 Initial assessment

You will undergo evaluation to confirm your Alzheimer’s disease diagnosis through specific tests that measure protein markers in your blood or brain scans if needed.

Your mental status will be assessed using a standard examination with a score range of 5 to 22.

Your level of agitation will be evaluated using specific assessment tools to ensure it meets the study criteria.

2 Caregiver confirmation

Your caregiver must be identified and confirmed to spend at least 10 hours per week with you.

The caregiver will need to attend all visits and help with medication management.

The caregiver will participate in assessments throughout the study.

3 Treatment period

You will receive either KarXT with KarX-EC capsules or a placebo (inactive capsules) to take by mouth.

The medication or placebo will be given according to a specific schedule that will be provided.

Neither you nor your doctor will know whether you are receiving the actual medication or placebo.

4 Regular assessments

Your agitation levels will be monitored regularly using specific rating scales.

Your overall condition will be evaluated throughout the study period.

The study will track changes in your behavior and agitation symptoms compared to when you started.

5 Study completion

The study will continue until the end of the prescribed treatment period.

Final assessments will be conducted to measure changes in your agitation levels.

Your overall response to the treatment will be evaluated using standardized measurements.

Who Can Join the Study?

You must have a confirmed diagnosis of Alzheimer’s disease (AD) with evidence from one of these tests:
- Previous brain scan showing amyloid deposits (amyloid PET scan)
- Previous spinal fluid test showing specific protein markers
- Blood test showing specific protein markers
Your score on the Mini-Mental State Examination (MMSE), which is a test that measures thinking and memory abilities, must be between 5 and 22
You must have a dedicated caregiver who:
- Spends at least 10 hours per week with you
- Can attend all study visits with you
- Will help you take medications as prescribed
- Agrees to participate in study assessments
You must have shown signs of agitation for at least two weeks before starting the study
You must have a certain level of agitation as measured by specific medical tests:
- A score of 4 or higher on the NPI Agitation/Aggression scale
- A score of 4 or higher on the CGI-S scale for agitation
You must show at least one of these behavioral patterns:
- One or more aggressive behaviors several times per week
- Two or more aggressive behaviors once or twice per week
- Three or more aggressive behaviors less than once per week
Both men and women may participate in the study

Who Cannot Join the Study?

History of schizophrenia or other psychotic disorders
Severe kidney disease requiring dialysis treatment
Current diagnosis of major depressive disorder
Known allergy or sensitivity to the study medication components
Participation in another clinical trial within the past 30 days
Unstable medical conditions that could interfere with the study procedures
History of substance abuse within the past 12 months
Use of prohibited medications that might interact with the study drug
Severe liver disease or abnormal liver function tests
History of seizures or other significant neurological conditions
Inability to comply with study procedures due to severe cognitive impairment
Presence of any condition that, in the investigator’s opinion, would make participation unsafe
Uncontrolled high blood pressure or significant heart problems
History of severe allergic reactions to medications
Pregnant women or women planning to become pregnant during the study period

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia	Bucharest	Romania
Spitalul Clinic de Psihiatrie “Dr. Gheorghe Preda” Sibiu	Sibiu	Romania
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Euromedica General Clinic Of Thessaloniki	Thessaloniki	Greece
Hospital Universitario Rio Hortega	Valladolid	Spain
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Henry Dunant Hospital Center	Athens	Greece
Opca Bolnica Varazdin	Varazdin	Croatia
Spitalul Clinic De Psihiatrie Si Neurologie Brasov	Brasov	Romania
Medical Center Saint Naum EOOD	Sofia	Bulgaria
Consorci Sanitari De Terrassa	Terrassa	Spain
Hospital Victoria Eugenia De La Cruz Roja Espanola	Sevilla	Spain
CNS Saude Lda.	Torres Vedras	Portugal
University General Hospital Of Ioannina	Ioannina	Greece
General University Hospital Of Patras	Patras	Greece
Hospital Ruber Juan Bravo	Madrid	Spain
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila	Bucharest	Romania
Eginitio Hospital	Athens	Greece
KBC Split	Split	Croatia
Institutul De Psihiatrie Socola Lasi	Iasi	Romania
Hospital Universitario Virgen De La Victoria	Malaga	Spain
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Outpatient Clinic for Indiv. Practice for Spec.Med. Care in Psychiatry-Dr.Madlena Dimitrova Borisova	Razgrad	Bulgaria
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian	Bucharest	Romania
Cak Fphcig Cmomugux Hgblahwl Cmezpxwvi	Constanta	Romania
Mjjkfv Hconrn Cfigxq Sltfe Eibm	Sofia	Bulgaria
Kciulrgg bcbxzosd cuvupo Rrqcyy (vwmnsntm Hiriuuhw Ctyunb Rylhrrh	Rijeka	Croatia
Auimqu Mpeiwpf Cupqap Smzl	Thessaloniki	Greece
Cuetyu Hepwdgagrt E Udijbzpzgsmsu Di Cuhwscm Eejdfy	Coimbra	Portugal
Mbxyjmx Ckifzb Mqutsukpei Pqunpc Oif	Pleven	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	30.10.2025
Croatia	Recruiting	30.10.2025
Greece	Recruiting	30.10.2025
Portugal	Recruiting	30.10.2025
Romania	Recruiting	30.10.2025
Spain	Recruiting	30.10.2025

Trial locations

Investigated drugs:

KarXT and KarX-EC are investigational medications being studied for treating agitation in people with Alzheimer’s disease. These medications are being tested together as a combination therapy.

KarXT is an experimental drug that works in the brain to help control agitated behaviors that can occur in people with Alzheimer’s disease. This medication aims to reduce symptoms like restlessness, aggression, and emotional distress.

KarX-EC is designed to work together with KarXT. The EC in its name likely indicates it has a special coating that controls how the medication is released in the body. It is being studied to see if it can enhance or complement the effects of KarXT in managing agitation symptoms.

Investigated diseases:

Dementia Alzheimer's type

Agitation Associated with Alzheimer’s Disease – A behavioral symptom that commonly occurs in people with Alzheimer’s disease, characterized by restlessness, emotional distress, and various forms of disruptive behavior. Patients may exhibit physical aggression, verbal outbursts, resistance to care, wandering, or repetitive actions. The condition typically fluctuates in severity throughout the day and tends to worsen as Alzheimer’s disease progresses. This behavioral disturbance can manifest as pacing, repeated movements, or constant demands for attention. The agitation often becomes more pronounced in unfamiliar environments or during times of stress.

Trial ID:

2025-520613-31-00

Protocol code:

CN012-0023

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of xanomeline tartrate and trospium chloride combination for treating agitation in Alzheimer’s disease patients

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