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Study on the Effectiveness and Safety of KarXT for Treating Psychosis in Patients with Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying a condition known as psychosis associated with Alzheimer’s disease. Psychosis in this context refers to symptoms such as hallucinations and delusions that can occur in people with Alzheimer’s disease. The trial will test a treatment called KarXT, which is being developed by Karuna Therapeutics Inc. The purpose of the study is to evaluate how well KarXT works in treating these symptoms compared to a placebo.

Participants in the study will be randomly assigned to receive either KarXT or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will last for several weeks, during which participants will be monitored for changes in their symptoms and any side effects they might experience.

The main goal is to see if there is an improvement in the symptoms of psychosis, such as hallucinations and delusions, by the end of the study period. Participants will have regular check-ups to assess their condition and the effectiveness of the treatment. The study aims to provide valuable information on the safety and effectiveness of KarXT for people with psychosis related to Alzheimer’s disease.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current medications.

A brain scan, either MRI or CT, is required if not done in the last five years to rule out other conditions.

2 baseline evaluation

A baseline evaluation is performed to measure the severity of psychosis symptoms using the Neuropsychiatric Inventory-Clinician (NPI-C) scale, focusing on hallucinations and delusions.

The Clinical Global Impression-Severity (CGI-S) scale is also used to assess the overall severity of symptoms.

3 medication administration

Participants receive either the investigational medication KarXT or a placebo. The study is double-blind, meaning neither the participant nor the study team knows which treatment is given.

The medication is administered over a period of 12 weeks. Dosage and frequency are determined by the study protocol.

4 ongoing assessments

Throughout the 12-week period, regular assessments are conducted to monitor the participant’s response to the treatment.

These assessments include repeating the NPI-C and CGI-S scales to track changes in symptoms.

5 final evaluation

At the end of the 12-week period, a final evaluation is conducted to measure any changes in symptoms from the baseline.

The primary focus is on the change in the NPI-C: Hallucinations and Delusions score.

Who Can Join the Study?

  • Must be a male or female aged between 55 and 90 years old.
  • Must have a score between 8 and 22 on the MMSE test, which is a simple test to check memory and thinking skills.
  • If taking certain medications for memory (cholinesterase inhibitors or memantine), the dose must have been stable for 6 weeks before starting the study and remain stable during the study.
  • Must be willing and able to visit the clinic as an outpatient, follow instructions, and comply with study requirements.
  • Body Mass Index (BMI) must be between 18 and 40. BMI is a measure of body fat based on height and weight.
  • Female participants must not be pregnant or breastfeeding. Women who can have children, or men whose partners can have children, must use effective birth control during the study and for at least 30 days after the last dose. Men cannot donate sperm for 30 days after the last dose.
  • Must understand the study and agree to participate. If unable to provide consent, a legal representative must consent, and the participant must agree to participate.
  • Must meet criteria for possible or probable Alzheimer’s Disease (AD).
  • Must have had a brain scan (MRI or CT) in the last 5 years to rule out other brain diseases. If not available, a new scan must be done during the screening.
  • Must have lived in the same home or assisted-living facility for at least 6 weeks before starting the study.
  • Must be able to move around, with or without help, and have a study partner who has regular contact, attends visits, helps with medication, and participates in study assessments.
  • Must have a history of psychotic symptoms, like hallucinations or delusions, for at least 2 months before starting the study.
  • Must have a score of 4 or higher on the CGI-S scale, which measures the severity of psychosis, at the start and during the study.
  • Must have a score of 6 or higher on the NPI-C test for hallucinations and delusions, and meet specific criteria for moderate to severe delusions or hallucinations at the start and during the study.

Who Cannot Join the Study?

  • Patients who do not have psychosis associated with Alzheimer’s Disease cannot participate. Psychosis means having trouble with reality, like seeing or hearing things that aren’t there (hallucinations) or having strong beliefs that aren’t true (delusions).
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, so it’s important to check if you fit within it.
  • Patients who are not able to give their own consent or do not have a legal representative to do so cannot participate. Consent means agreeing to take part in the study after understanding what it involves.
  • Patients with other serious medical conditions that might interfere with the study cannot participate. This means if you have another illness that could affect the study results, you might not be able to join.
  • Patients who are currently participating in another clinical trial cannot participate. This is to make sure the results of this study are not affected by other treatments or studies.
  • Patients who have had a recent change in their medication for Alzheimer’s Disease cannot participate. This is to ensure that any changes in symptoms are due to the study treatment and not other medications.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Algemeen Ziekenhuis Delta Roeselare Belgium
University General Hospital Of Heraklion Heraklion Greece
Athens Naval Hospital Athens Greece
Henry Dunant Hospital Center Athens Greece
Semmelweis University Budapest Hungary
Jessa Ziekenhuis Hasselt Belgium
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Santa Familia PTG Łódź Lodz Poland
Pgfgvhpvvm Kaku Pecs Hungary
Hhvpkw Dzouxwesto ajc Tadqsnhhebg Cvayub oh Akprse Athens Greece
Opjntli Bjhyafdi Ntxknda Ddpjoyzmrix Cgwimq Ohjebzpksgy Its Ksrhdvj Hyohcmy Khnnayktf Guqmnpsivosa Ogtbojw Apnxpuhsunwdvt Ssu z ojfs Scinawa Poland
Uxlaiimtmg Gzebrcl Hpyppacv Aspohmi Athens Greece

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
31.03.2024
Greece Greece
Not recruiting
31.03.2024
Hungary Hungary
Not recruiting
31.03.2024
Poland Poland
Not recruiting
31.03.2024

Trial locations

KarXT is a medication being studied for its potential to treat psychosis in patients with Alzheimer’s disease. It is designed to help reduce symptoms such as hallucinations and delusions, which are common in this condition. The trial aims to assess how effective KarXT is in improving these symptoms compared to not receiving the active treatment.

Investigated diseases:

Psychosis Associated with Alzheimer’s Disease – This condition involves the presence of psychotic symptoms such as hallucinations and delusions in individuals diagnosed with Alzheimer’s disease. Alzheimer’s disease is a progressive neurological disorder that leads to memory loss and cognitive decline. As the disease advances, some individuals may experience psychosis, which can manifest as seeing or hearing things that are not present or holding false beliefs. These symptoms can significantly impact the individual’s behavior and interactions with others. The progression of psychosis in Alzheimer’s disease can vary, with symptoms potentially becoming more pronounced over time. Understanding and managing these symptoms is crucial for improving the quality of life for affected individuals and their caregivers.

Trial ID:
2023-504416-16-00
Protocol code:
KAR-032
NCT ID:
NCT06126224
Trial Phase:
Therapeutic confirmatory (Phase III)

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