Study on the Safety and Effects of NPI-001 (Acetylcysteine Amide) for Patients Aged 50-85 with Mild Cognitive Impairment or Mild Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying Alzheimer’s Disease, a condition that affects memory and thinking skills. The trial will test a new treatment called NPI-001 (AT-001), which is a tablet taken by mouth. The main goal of the study is to assess the safety and tolerability of this treatment in people with mild cognitive impairment or mild dementia due to Alzheimer’s Disease.

Participants in the study will be randomly assigned to receive either the NPI-001 tablet or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for up to 12 months, during which participants will have regular check-ups and tests, including MRI scans to monitor changes in the brain. These tests will help researchers understand how the treatment affects the brain and whether it can reduce harmful substances associated with Alzheimer’s Disease.

The study will also involve blood tests to measure changes in specific proteins and other markers related to Alzheimer’s Disease. Participants will be monitored for any side effects or changes in their health throughout the study. This research aims to provide valuable information about the potential benefits and risks of NPI-001 for people living with Alzheimer’s Disease.

1 joining the study

Upon joining the study, the participant will be required to provide informed consent. This means agreeing to participate after understanding the study’s purpose, procedures, and potential risks and benefits.

A study partner, such as a spouse or caregiver, must be identified. This person will assist the participant throughout the study.

2 initial assessments

The participant will undergo a series of initial assessments. These include blood tests and brain scans such as MRI and amyloid PET scans to establish a baseline for the study.

Cognitive tests will be conducted to evaluate memory and thinking skills. These tests require the participant to read, write, and speak clearly.

3 medication administration

The participant will receive either the study medication NPI-001 (AT-001) or a placebo. The placebo is a white oral tablet that does not contain the active substance.

The medication is taken orally in tablet form. The dosage and frequency will be determined by the study team and may be adjusted during the trial.

4 ongoing assessments

Throughout the study, the participant will have regular follow-up visits. These visits will include blood tests and cognitive assessments to monitor the effects of the medication.

The participant will also undergo periodic brain scans to assess any changes in brain structure or function.

5 monitoring and safety checks

The participant’s health will be closely monitored for any adverse events or side effects. This includes regular checks of vital signs, clinical lab values, and physical examinations.

The study team will evaluate the participant’s response to the medication and make any necessary adjustments to ensure safety and tolerability.

6 completion of the study

At the end of the study period, which lasts up to 12 months, the participant will undergo final assessments. These will include blood tests, brain scans, and cognitive evaluations.

The study team will review all collected data to determine the efficacy and safety of the medication.

Who Can Join the Study?

The participant must be a male or female aged between 50 and 84 years old.
The participant must have MCI (Mild Cognitive Impairment) or mild dementia due to Alzheimer’s disease, as diagnosed by a doctor, and must be receiving standard care for Alzheimer’s disease.
The participant must be willing to have blood tests at the start and during the study, for up to 12 months.
The participant must be willing to have MRI (Magnetic Resonance Imaging) and amyloid PET scans of the brain. These are special imaging tests to look at the brain.
The participant must have given informed consent to take part in the study. This means they understand the study and agree to participate.
The participant must have a spouse, close relative, or caregiver who lives with them or helps take care of them, to be a study partner.
The participant must have a MMSE (Mini-Mental State Examination) score between 21 and 27. This is a test that measures cognitive function.
If the participant is taking other medications, they must have been on stable doses for at least 3 months before the study starts, and the doses should remain stable during the study.
The participant must be able to read, write, and speak clearly for the cognitive tests, and have good enough eyesight and hearing to complete these tests.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Alzheimer’s Disease cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
Patients who have any medical condition that the study team believes would make participation unsafe cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a history of certain brain conditions that could interfere with the study results cannot participate.
Patients who are unable to undergo MRI imaging (a type of scan that uses magnets and radio waves to create pictures of the inside of the body) cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Sanos A/S	Gandrup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	28.04.2025
Iceland	Recruiting	28.04.2025

Trial locations

Investigated drugs:

Acetylcysteine Amide

NPI-001 (AT-001) is a medication being studied for its potential to help people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. This medication is taken by mouth and is being tested to see if it is safe and well-tolerated by patients. Researchers are also looking at how it might affect certain markers in the body that are related to Alzheimer’s disease. The goal is to see if this medication can help improve or stabilize the symptoms of Alzheimer’s disease, making it easier for patients to manage their daily activities and maintain their quality of life.

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 cognitive functions. 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 changes in personality and behavior, including mood swings and social withdrawal. The progression of the disease varies among individuals, but it generally worsens over time, affecting daily living activities.

Trial ID:

2024-519497-39-00

Protocol code:

AT-24-03

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of NPI-001 (Acetylcysteine Amide) for Patients Aged 50-85 with Mild Cognitive Impairment or Mild Alzheimer’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?