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Study on the Safety and Effects of NSC001 and Trospium Chloride for Patients with Mild to Moderate Alzheimer's Disease

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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 new treatment for Alzheimer's Disease, which is a condition that affects memory and thinking skills. The study will use a medication known by its code name NSC001, which is a type of drug that targets specific brain receptors to potentially improve symptoms in people with mild to moderate Alzheimer's Disease. Another medication, Trospium Aristo, may also be used in combination with NSC001. Trospium Aristo is typically used to help with muscle spasms and bladder issues.

The purpose of this study is to determine how safe and tolerable NSC001 is for patients, with or without the addition of Trospium Aristo. Participants will be randomly assigned to different groups, with some receiving the actual medication and others receiving a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving which treatment, ensuring unbiased results. The trial will last for a period of 16 weeks, during which participants will take the medication orally in the form of capsules or film-coated tablets.

Throughout the study, participants will be monitored for any changes in their health, including side effects, vital signs, and overall well-being. Regular assessments will be conducted to track any improvements or changes in their condition. The study aims to gather valuable information that could lead to better treatment options for those living 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
Upon joining the clinical trial, the participant will attend an initial visit. During this visit, the participant will undergo a series of assessments to confirm eligibility for the study. These assessments may include cognitive tests, medical history review, and physical examinations.
The participant will be required to provide informed consent, confirming understanding and agreement to participate in the trial. This consent is necessary before any study-specific procedures can begin.
Step 2
Baseline assessments
Baseline assessments will be conducted to gather initial data on the participant's health and cognitive status. This may involve tests such as the Mini Mental State Examination (MMSE) and other cognitive evaluations.
The participant's current medications, including any acetylcholinesterase inhibitors (AChEIs) like donepezil, galantamine, or rivastigmine, will be reviewed to ensure stability for at least three months prior to the trial.
Step 3
Medication administration
The participant will be randomly assigned to receive either the investigational medication NSC001 or a placebo. The medication will be administered in the form of a capsule, taken orally.
The dosage and frequency of the medication will be determined by the study protocol. The participant will be required to take the medication as directed for the duration of the trial.
Step 4
Regular follow-up visits
Throughout the trial, the participant will attend regular follow-up visits. These visits are designed to monitor the participant's health, assess the effects of the medication, and ensure compliance with the study protocol.
During these visits, various tests and assessments will be conducted, including evaluations of vital signs, laboratory tests, and cognitive assessments.
Step 5
Final assessment
At the end of the trial period, a final assessment will be conducted. This assessment will evaluate the participant's overall health and cognitive status, as well as any changes that may have occurred during the trial.
The participant will be asked to return any unused medication and provide feedback on their experience in the trial.

Who can join the trial?

16 criteria

The participant and a reliable caregiver must be willing and able to sign a consent form to join the study. The participant's mental ability to consent will be checked by a doctor.
The participant must score between 18 and 26 on a test called the Mini Mental State Examination (MMSE), which checks mental abilities.
The participant must score 4 or less on the Modified Hachinski Ischemic Scale (mHIS)</b), unless a recent MRI scan shows no blood vessel-related causes for dementia.
The participant must be taking medications called AChEIs (such as donepezil, galantamine, or rivastigmine) and must have been on a stable dose for at least 3 months before starting the study.
The participant must have good enough vision, hearing, and movement abilities to complete the study tests.
The participant must be able to swallow size 2 capsules.
The participant must be in reasonably good health, according to the study doctor, to take part in the 21-week study.
The participant must agree to have a genetic test called ApoE genotyping. The results may be shared with the participant if the study doctor decides to do so.
The participant must have a caregiver who can spend at least 10 hours a week with them, help them take the study medication correctly, attend study visits, and assist with study procedures. The caregiver must also be willing to provide information for caregiver assessments and sign a consent form.
The participant must be between 50 and 85 years old at the time of giving consent.
Female participants must have been through menopause for at least 2 years or have had surgery to prevent pregnancy at least 6 months before the study.
Male participants with partners who can become pregnant must agree to use reliable birth control methods during the study and for 6 months after stopping the study treatment.
The participant must have a clinical diagnosis of Alzheimer's Disease (AD) in the mild to moderate stages, according to specific criteria used by experts.
The participant must have test results from the last 3 years that support the diagnosis of AD, such as a positive Amyloid PET Scan or a specific blood test result (p-tau217) indicating brain changes related to AD.
There must be evidence of mental decline over the past year, based on caregiver observations, medical records, or cognitive tests.
The participant must have had a brain scan (MRI or CT) within the last 12 months that supports the diagnosis of mild to moderate AD and shows no other significant brain issues. If no recent scan is available, a new MRI must be done before starting the study treatment.

Who cannot join the trial?

9 criteria

Participants must not have any other serious medical conditions that could interfere with the study.
Participants should not have a history of severe allergic reactions to any medications.
Participants must not be currently participating in another clinical trial.
Participants should not have any significant psychiatric disorders, which are mental health conditions that affect mood, thinking, and behavior.
Participants must not have any substance abuse issues, which means they should not be using drugs or alcohol in a way that could affect their health or the study.
Participants should not be pregnant or breastfeeding.
Participants must not have any uncontrolled medical conditions, meaning health issues that are not being managed well with treatment.
Participants should not have any known sensitivity or allergy to the study medication.
Participants must not have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

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Verified sites

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

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Verified
Palermo, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Verified
Foggia, Italy
Katholisches Klinikum Bochum gGmbH
Responsive
Bochum, Germany

Trial locations

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Investigated drugs

NSC001
is a new medication being tested to see if it can help people with mild to moderate Alzheimer's disease. It works by targeting a specific part of the brain that is involved in memory and thinking. The goal is to see if this medication can improve symptoms or slow down the progression of the disease. Researchers are also checking if it is safe for people to use and if it causes any side effects.
Trospium
is a medication that is sometimes used to treat bladder problems, but in this trial, it is being tested to see if it can help when used together with NSC001. The researchers want to find out if combining these two medications can make the treatment more effective for people with Alzheimer's disease. They are also looking at whether this combination is safe and well-tolerated by the participants in the study.

What is already known about the treatment

NSC001 – NSC001 is administered orally and is currently being studied in clinical trials for its potential use in treating mild to moderate Alzheimer's Disease. This medication is in the experimental phase and is not yet widely recognized in medical literature as a standard treatment. It is designed to help improve cognitive function by specifically targeting and activating the M1 muscarinic receptors in the brain, which are involved in memory and learning processes. NSC001 is classified as a selective muscarinic M1 agonist, meaning it selectively stimulates these receptors to potentially enhance brain function in Alzheimer's patients.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration of brain cells. It primarily affects memory, thinking, and behavior, gradually impairing a person's ability to carry out daily activities. The disease typically begins with mild memory loss and confusion, which can progress to severe memory impairment and disorientation. As it advances, individuals may experience difficulty in recognizing familiar people, places, and objects. Over time, Alzheimer's Disease can lead to significant cognitive decline, affecting language, reasoning, and judgment. The progression of the disease varies among individuals, but it generally worsens over several years.