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Study on Masupirdine for Treating Agitation in Alzheimer's Dementia Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Masupirdine on patients experiencing agitation related to Alzheimer's disease. Alzheimer's disease is a condition that affects memory and other important mental functions. Agitation is a common symptom in people with Alzheimer's, characterized by restlessness, irritability, and sometimes aggressive behavior. The purpose of this study is to evaluate how effective and safe Masupirdine is in reducing these symptoms.

Participants in the study will receive either Masupirdine or a placebo, which is a substance with no active medication. The study will last for 12 weeks, during which participants will take the medication in tablet form by mouth. The study will compare two different doses of Masupirdine, 50 mg and 100 mg, to see which is more effective. Throughout the study, participants will be monitored for any changes in their symptoms and overall health.

The study aims to measure changes in agitation symptoms using specific criteria, such as physical aggression and verbal aggression. Participants will also be assessed for any improvements in their overall condition and any changes in their memory and cognitive abilities. The study will help determine if Masupirdine can be a beneficial treatment for managing agitation in patients with Alzheimer's disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Visit and Screening
The initial visit involves a comprehensive screening process to confirm eligibility for the study. This includes a review of medical history, a physical examination, and cognitive assessments.
Participants must have a diagnosis of dementia of the Alzheimer's type and exhibit symptoms of agitation. An MRI or CT scan is required to support the diagnosis.
Step 2
Randomization and Baseline Assessment
Participants are randomly assigned to receive either masupirdine or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.
Baseline assessments are conducted to measure agitation levels and other cognitive functions. These assessments will be used for comparison throughout the study.
Step 3
Medication Administration
Participants take masupirdine orally in tablet form. The dosage is either 50 mg or 100 mg, administered daily for a duration of 12 weeks.
Participants continue their current treatment with cholinesterase inhibitors or memantine, if applicable, and maintain stable doses of any other medications for dementia or agitation.
Step 4
Regular Monitoring and Assessments
Participants attend regular visits for monitoring and assessments at weeks 2, 4, 8, and 12. These visits include evaluations of agitation, cognitive function, and overall health.
The primary focus is on changes in agitation levels, as measured by specific scales and criteria.
Step 5
Final Assessment and Study Completion
At the end of the 12-week period, a final assessment is conducted to evaluate the overall effects of the treatment.
Participants' scores on various scales are compared to baseline measurements to determine any changes in agitation and cognitive function.

Who can join the trial?

19 criteria

The participant and/or their caregiver must understand and sign a consent form before starting the study.
The participant must be at least 50 years old and have a diagnosis of dementia related to Alzheimer's disease.
The participant must have shown signs of agitation for at least 2 weeks before the first visit.
The participant must have confirmed agitation according to specific criteria for cognitive disorders.
The participant must have had an MRI or CT scan after Alzheimer's symptoms began, showing results consistent with dementia and no other significant health issues.
The participant must score between 5 and 26 on a test called the MMSE, which checks mental abilities.
The participant must have significant agitation or aggression, with a score of 4 or higher on a specific assessment at the first two visits.
The participant must have been on stable doses of certain Alzheimer's medications for at least 3 months before the first visit and likely to continue the same dose during the study.
The participant must not have changed medications for behavior related to Alzheimer's within 4 weeks before the second visit. A medication called lorazepam can be used in small doses for a short time, and its use must be recorded.
The participant can use certain sleep medications, but they must not be taken within 8 hours before any study assessments.
The participant can use certain anxiety or depression medications, as long as the dose has been stable for at least 4 weeks before the first visit.
The participant can use supplements or treatments for dementia, agitation, or sleep, like omega-3, melatonin, or vitamin B12, if the dose has been stable for at least 4 weeks before the first visit and remains stable during the study.
The participant must have a caregiver who can provide accurate information about their abilities and accompany them to study visits. The caregiver should spend at least 8 hours per week with the participant.
The participant can live independently, with in-home services, or in assisted living or nursing homes, as long as the caregiver ensures the study medication is taken.
The participant must have vision and hearing (with correction if needed) sufficient to follow testing procedures, and both the participant and caregiver must be able to read and understand written information.
The participant must not have significant health issues based on general health checks, physical exams, neurological exams, heart tests (ECG), or lab tests. Certain liver tests must not be more than 1.5 times the normal limit.
The participant must have a body mass index (BMI) greater than 18.5 at the first visit.
The participant must be willing and able to take part in all study activities, including giving blood samples for tests.
The participant must be able to travel to the study site for scheduled visits, except for those living in nursing homes.

Who cannot join the trial?

5 criteria

Patients who do not have agitation related to Dementia of the Alzheimer's Type cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

EMC Instytut Medyczny S.A.
Verified
Poznan, Poland
Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
KBC Zagreb
Responsive
Zagreb, Croatia

Trial locations

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Investigated drugs

Masupirdine (SUVN-502) is being studied for its potential to help reduce symptoms of agitation in people with Alzheimer's disease. Agitation can include behaviors like physical aggression, excessive movement, and verbal aggression. This medication is being tested to see if it can safely and effectively improve these symptoms over a 12-week period.

Masupirdine

What is already known about the treatment

Masupirdine – Masupirdine is administered orally in tablet form and is currently being studied in clinical trials for its potential use in treating agitation associated with dementia of the Alzheimer's type. It is not yet approved for general medical use, as it is still under investigation to determine its efficacy and safety. The main therapeutic indication for masupirdine is to alleviate symptoms of agitation, such as physical aggression, excessive motor activity, and verbal aggression, in individuals with Alzheimer's-related dementia. At the molecular level, masupirdine is believed to work by modulating neurotransmitter systems in the brain, although the exact mechanism is still being researched. It is classified pharmacologically as a potential treatment for neuropsychiatric symptoms in dementia.

Investigated diseases

Agitation with Dementia of the Alzheimer's Type – This condition is characterized by increased restlessness and irritability in individuals with Alzheimer's disease. It often manifests as physical aggression, excessive motor activity, and verbal aggression. These symptoms can fluctuate in intensity and may be triggered by environmental changes or internal discomfort. As the dementia progresses, the frequency and severity of agitation episodes may increase. This condition can significantly impact the quality of life for both the affected individuals and their caregivers. Understanding and managing these symptoms is crucial for improving daily interactions and overall well-being.