Study of KarXT (trospium chloride and xanomeline tartrate) and KarX-EC (xanomeline tartrate) for cognitive impairment in mild to moderate Alzheimer’s disease

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What is this study about?

This study aims to test the effectiveness of medications called KarXT and KarX-EC in treating thinking and memory problems in people with Alzheimer’s Disease. These medications contain active substances called trospium chloride and xanomeline tartrate, which are taken as capsules by mouth.

The study will involve people with mild to moderate Alzheimer’s Disease, who will receive either the study medications or placebo for 24 weeks. The medications are being tested to see if they can help improve cognitive function (thinking abilities) and daily functioning in people with Alzheimer’s Disease.

During the study, participants will take the medication daily and attend regular check-ups where their mental abilities and overall condition will be assessed. The study will track any changes in participants’ ability to think, perform daily activities, and their overall health status. Healthcare providers will monitor participants’ safety throughout the study period.

1 Initial screening

You will undergo screening to confirm if you meet the study requirements for mild to moderate Alzheimer’s Disease

Your thinking abilities will be tested using the MMSE test (a standard memory and thinking assessment). Your score should be between 12 and 22

You must be between 60 and 85 years old to participate

You need to have a caregiver who spends at least 10 hours per week with you and can attend all study visits

2 Medication requirements check

If you are currently taking memory medications (AChEIs and/or memantine), you must have been on a stable dose for at least 12 weeks

You will need to maintain this same dose throughout the study

3 Treatment period

The study will last 24 weeks (approximately 6 months)

You will receive either KarXT + KarX-EC capsules or placebo capsules (inactive treatment)

The medication will be taken by mouth

Your caregiver will help ensure you take the medication as prescribed

4 Monitoring and assessments

Your thinking abilities will be tested regularly using the ADAS-Cog11 test

Your daily activities will be assessed using the ADCS-ADL assessment

Your behavior will be evaluated using the NPI assessment

Regular health checks will include vital signs, heart tests (ECG), weight measurements, and laboratory tests

Any side effects or health changes will be monitored throughout the study

5 Final assessment

At week 24, final assessments will be conducted to measure changes in your thinking abilities and overall function

Your caregiver will provide information about changes in your daily activities and behavior

Who Can Join the Study?

  • Must be between 60 and 85 years old, both men and women can participate
  • Must have a MMSE score between 12 and 22 during screening (MMSE is a simple test that checks memory and thinking skills)
  • Must have a dedicated caregiver who:
    • Spends at least 10 hours per week with the participant
    • Can attend all study visits
    • Will help monitor the participant’s condition
    • Will help with taking medications
    • Will ensure study procedures are followed
  • If currently taking memory medications (AChEIs and/or memantine):
    • Must have been on the same dose for at least 12 weeks before screening
    • Must agree to stay on the same dose throughout the study

Who Cannot Join the Study?

  • History of severe allergic reactions or sensitivity to similar medications
  • Current diagnosis of major psychiatric disorders (such as schizophrenia, bipolar disorder, or severe depression)
  • Significant heart problems or uncontrolled high blood pressure
  • Severe liver or kidney disease
  • History of seizures or other neurological conditions besides Alzheimer’s Disease
  • Current use of medications that could interact with the study drug
  • Participation in another clinical trial within the past 30 days
  • Inability to follow study procedures or attend regular visits
  • Substance abuse within the past year
  • Dementia caused by conditions other than Alzheimer’s Disease
  • Severe vitamin B12 or folate deficiency
  • History of stroke or transient ischemic attack (temporary stroke-like symptoms) in the past 6 months
  • Unstable medical conditions that could interfere with the study
  • Presence of any medical devices that would prevent brain imaging if needed

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Hopitaux Universitaires Pitie Salpetriere Paris France
Hospital Universitario 12 De Octubre Madrid Spain
Clinical Research Services Turku CRST Oy Turku Finland
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
CRST Helsinki Oy Helsinki Finland
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
Brain Research Center Amsterdam B.V. Amsterdam The Netherlands
Brain Research Center Zwolle B.V. Zwolle The Netherlands
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
Spitalul Clinic De Psihiatrie Si Neurologie Brasov Brasov Romania
University Of Eastern Finland Kuopio Finland
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
CNS Saude Lda. Torres Vedras Portugal
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Brain Research Center Den Bosch B.V. s-Hertogenbosch The Netherlands
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
General University Hospital Of Patras Patras Greece
Hospital Ruber Juan Bravo Madrid Spain
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
Centre Hospitalier Universitaire De Rennes Rennes France
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Hvrkhths Ucigrnbtjslti Makdwfo Db Vlbbfymzur Santander Spain
Bgzsudty Cmswpl Srhblh Constanta Romania
Eny Sqsaelr Sbr z oqnb Katowice Poland
Pttfc Hjtfjafvb Psnlusssmoj Wroclaw Poland
Uazfilhsjy Hjtudywk Cccfgsf Cologne Germany
Aypseihgdw Pjjrmzmv Hqyvgdkr Dc Mssiwsfgg Marseille France
Ciqw Ds Nnwjq Vandoeuvre Les Nancy France
Acsrgqy Oqxhwsajxxa Udkjzdofuigef Opqevthh Rgdzvkj Foggia Italy
Kilurkgt ddp Unjjlmoizbae Mvxbkolc Ajk Munich Germany
Ifglihfc Zjciwez Dm Bpuksrbvovijvpdzd Oświęcim Poland
Hurcjgua Utgxzwdvehqguu Swxtklpoph &bbwyem Hlfjsik dn Hdcputspeie STRASBOURG, Alsace France
Cuvcap Hgyonjueaq E Uhpzrksvatzqy Dq Cryvkro Ecgqnx Coimbra Portugal
Slvype Tdbqterjfti Oa Turku Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
25.07.2025
France France
Recruiting
25.07.2025
Germany Germany
Recruiting
25.07.2025
Greece Greece
Recruiting
25.07.2025
Italy Italy
Recruiting
25.07.2025
Poland Poland
Recruiting
25.07.2025
Portugal Portugal
Recruiting
25.07.2025
Romania Romania
Recruiting
25.07.2025
Spain Spain
Recruiting
25.07.2025
The Netherlands The Netherlands
Recruiting
25.07.2025

Trial locations

KarXT is an investigational medication being studied for treating cognitive impairment (problems with thinking and memory) in people who have mild to moderate Alzheimer’s disease. It works by targeting specific brain receptors that are involved in cognitive function.

KarX-EC is a complementary medication being studied alongside KarXT. Together, these medications are being tested to see if they can help improve thinking abilities and daily functioning in people with Alzheimer’s disease.

Investigated diseases:

Alzheimer’s Disease – A progressive brain disorder that gradually destroys memory, thinking skills, and the ability to carry out simple tasks. The disease begins with mild memory loss and confusion, which slowly becomes more severe over time. In mild to moderate stages, people experience increasing problems with memory, planning, language, and spatial awareness. The condition affects the parts of the brain that control thought, memory, and language. During these stages, individuals may have difficulty remembering recent events, following conversations, and managing daily activities. Changes in mood and personality may also occur, with some people becoming anxious, suspicious, or easily upset.

Trial ID:
2025-520747-32-00
Protocol code:
CN012-0052
NCT ID:
NCT06976203
Trial Phase:
Therapeutic confirmatory (Phase III)

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