The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Women´s Health Institute

Medicina Interna - Ensayos Clinicos

Morehead City, NC

Greensboro, NC

San Juan, PR

Atlanta, GA

Ormond Beach, FL

Daytona Beach, FL

Port Orange, FL

Orlando, FL

Tampa, FL

Miami Lakes, FL

Elizabeth Jimenez

Hialeah, FL

Miami, FL

Homestead, FL

Bonita Springs, FL

Naples, FL

Flowood, MS

Plano, TX

Scottsdale, AZ

Chandler, AZ

Anaheim, CA

Long Beach, CA

Costa Mesa, CA

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

Bountiful, UT

Jenna Leger

Bristol-Myers Squibb (BMS)

1. Study Overview NeuroTherapia Inc. is conducting a clinical study to explore the safety and effects of a new drug called NTRX- 07. This drug targets people with mild cognitive impairment (MCI) or mild to moderate Alzheimer's disease (AD). The study's primary focus is on safety and how the drug interacts with the body over a short-term period of 28 days. This research is important as it aims to find new ways to manage symptoms and slow the progression of AD.
2. Key Objectives Primary Objective:

   * To assess the safety and tolerability of NTRX-07 in patients with AD.
   * Safety and tolerability will be measured by monitoring any side effects or adverse events in participants during and after the treatment period.

   Secondary Objective:
   * To study how NTRX-07 is processed by the body, including how it is absorbed, distributed, metabolized, and eliminated.
   * This includes measuring the drug levels in the blood and cerebrospinal fluid (CSF) over time.
3. Study Design • Type of Study:

   o A randomized, double-masked, placebo-controlled study. "Randomized" means participants are randomly assigned to receive either the actual drug (NTRX-07) or a placebo (an inactive substance). "Double-masked" indicates that neither the participants nor the researchers know who receives the real drug or the placebo, reducing bias and ensuring objective results.

   • Participants:
   * 48 individuals with MCI or mild to moderate AD.

     • Treatment Groups:
   * Participants will be split into two groups: 24 will receive NTRX-07, and 24 will receive a placebo.

     • Duration:
   * The study will last up to 7-10 weeks for each participant, including a 28-day period during which they take the drug or placebo daily.
4. Study Procedures

   • Screening Period:
   * Before starting the treatment, participants will undergo a screening period of up to 45 days. During this time, they will have tests to confirm their eligibility, including physical exams, blood tests, cognitive assessments, and brain imaging (MRI).

     • Treatment Period (28 days):
   * Participants will take the study drug or placebo daily for 28 days. During this period, they will visit the study center for evaluations, including safety checks, cognitive tests, blood and CSF sampling, and EEG tests (to measure brain activity).

     • Follow-Up:
   * After the treatment period, participants will have a follow-up visit 7 days later for final safety assessments.
5. Safety Monitoring and Assessments

   * The study's primary focus is on safety. Researchers will monitor participants closely for any adverse events, such as side effects, throughout the study.
   * Safety assessments will include monitoring vital signs (blood pressure, heart rate, temperature), conducting laboratory tests (blood and urine analysis), performing physical examinations, and using electrocardiograms (ECGs) to monitor heart health.
6. Exploratory Assessments

   • Although this study primarily focuses on safety, researchers will also conduct exploratory assessments to observe any potential positive effects of NTRX-07 on brain function and symptoms of AD. These will include:

   o Cognitive Testing:
   * Standard tests like the AD Assessment Scale-Cognitive Subscale (ADAS-cog) and the Mini-Mental State Examination (MMSE) will be used to evaluate any changes in cognitive function.

     o Brain Imaging:
   * MRI scans will help assess changes in brain structure and inflammation.

     o Biomarkers:
   * Blood and CSF samples will be analyzed for specific biomarkers related to inflammation, brain health, and AD progression.
7. Eligibility Criteria

   * Inclusion Criteria:

     * Individuals aged 65-88 with a confirmed diagnosis of MCI or mild to moderate AD.
     * Must have a caregiver who can assist with the study requirements.
     * Must be able to undergo specific procedures like MRI scans and CSF sampling.
   * Exclusion Criteria:

     * Individuals with other significant health conditions or history of neurological disorders other than AD.
     * Those currently participating in another clinical trial or have certain medication restrictions.
8. Importance of the Study AD is a progressive condition that affects memory, thinking, and behavior. Current treatments only manage symptoms temporarily, and there is an need for new therapies. NTRX-07 is a novel drug that has shown promise in animal studies, potentially reducing brain inflammation, clearing harmful proteins, and improving memory and learning. This study is an essential step toward understanding if NTRX-07 can offer a safe and effective treatment option for people with AD.
9. Summary This clinical trial is designed to test the safety and processing of a new drug, NTRX-07, in people with MCI or mild to moderate AD. Participants will be carefully monitored for any side effects while researchers also gather data on the drug's impact on brain function. If successful, this study could lead to more advanced trials and, ultimately, a new treatment option for those affected by AD.

A Study of NTRX-07 in Participants With Alzheimer's Disease

NeuroTherapia, Inc.

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

Chorzow, Poland

Clinical Trial Center

Richmond Behavioral Associates

Ozark, MO

Memory Center

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Okeechobee, FL

Miami,, FL

Canoga Park, California

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Prague, Czech Republic

Miami Springs, FL

Find clinical trials for Alzheimer's Disease in Budapest, Budapest

Related conditions:

Alzheimer's Disease trials near Budapest, Budapest, HUN:

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

A Study of NTRX-07 in Participants With Alzheimer's Disease (SPPN-AD)

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Find clinical trials for Alzheimer's Disease in .css-epvm6{white-space:nowrap;}Budapest, Budapest

Related conditions:

Alzheimer's Disease trials near Budapest, Budapest, HUN:

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

A Study of NTRX-07 in Participants With Alzheimer's Disease (SPPN-AD)

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Find clinical trials for Alzheimer's Disease in Budapest, Budapest