Study on the Safety and Effects of NTRX-07 for Patients with Mild Cognitive Impairment or Mild to Moderate Alzheimer’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called NTRX-07 for individuals with Mild Cognitive Impairment (MCI) or Mild to Moderate Alzheimer’s Disease (AD). Alzheimer’s Disease is a condition that affects memory and thinking skills, and Mild Cognitive Impairment is an early stage of memory loss or other cognitive ability loss. The study aims to evaluate the safety and how well people tolerate the treatment when taken for 28 days.

Participants in the study will receive either the active drug NTRX-07 or a placebo, which looks like the active drug but does not contain the active substance. The study is designed to be “double-masked,” meaning neither the participants nor the researchers will know who is receiving the active drug or the placebo during the trial. This helps ensure that the results are not influenced by expectations about the treatment.

The trial will also look at how the body processes NTRX-07 by studying its presence in the blood and cerebrospinal fluid, which is the fluid surrounding the brain and spinal cord. The study will last for a total of 28 days, during which participants will be closely monitored for any side effects or changes in their condition. The goal is to gather information that could help in developing effective treatments for Alzheimer’s Disease and Mild Cognitive Impairment in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, weight, and health status.

Participants must be between 65-80 years old, with a body weight of 55-110 kg and a body mass index (BMI) between 18-35 kg/m².

2 baseline evaluation

A baseline evaluation is performed to assess cognitive function and confirm the diagnosis of mild cognitive impairment (MCI) or mild to moderate Alzheimer’s disease (AD).

This includes tests such as the Clinical Dementia Rating (CDR) and the Mini-Mental State Examination (MMSE).

3 medication administration

Participants receive the study medication, NTRX-07, or a placebo. The medication is administered orally in the form of a tablet.

The dosage is 45 mg per tablet, taken once daily for a duration of 28 days.

4 monitoring and follow-up

Throughout the 28-day period, participants are monitored for any adverse effects and changes in health status.

Regular follow-up visits are scheduled to assess the safety and tolerability of the medication.

5 final assessment

At the end of the 28-day period, a final assessment is conducted to evaluate the overall effects of the medication.

This includes measuring plasma and cerebrospinal fluid (CSF) levels to understand how the body processes the medication.

Who Can Join the Study?

Participants must be between 65 and 80 years old when they sign the consent form.
Body weight should be between 55 and 110 kg, and body mass index (BMI) should be between 18 and 35. BMI is a measure of body fat based on height and weight.
Male participants must agree to either not have heterosexual intercourse or use a condom during intercourse for at least 90 days after the last dose of the study drug. They should also be aware that their female partner should use a highly effective birth control method.
Female participants must be unable to have children, either because they are at least two years past menopause or have been surgically sterilized.
Participants should have a Clinical Dementia Rating (CDR) between 0.5 and 2.0. This is a scale used to measure the severity of dementia symptoms. They should also have memory scores that match mild cognitive impairment or mild to moderate Alzheimer’s Disease.
Participants must have a pTau 217 test result that matches Alzheimer’s Disease or a recent amyloid test within the last two years. These tests help confirm Alzheimer’s Disease.
If participants were in a previous study involving amyloid-directed treatments, they must have a negative ARIA report. ARIA is a type of brain scan result.
Participants should have medical records showing Alzheimer’s Disease symptoms started at age 60 or later.
Participants should not have active depression and should have a Geriatric Depression Score of less than 6. This score helps measure depression in older adults.
Participants should not have changed their use of certain Alzheimer’s medications, like acetylcholinesterase inhibitors or memantine, in the past six months and should not plan to start these medications during the study.
Participants must live at home with a reliable caregiver who sees them at least three times a week for 10 hours or more and can help with taking the study drug.
Participants and their caregivers must provide written consent, showing they agree to participate in the study.

Who Cannot Join the Study?

Patients with any other serious health condition that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients with a history of drug or alcohol abuse.
Patients who are pregnant or breastfeeding.
Patients who have an allergy to the study medication or its ingredients.
Patients who are unable to comply with the study procedures or follow-up visits.

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
Neuro Health Centrum s.r.o.	Brno	Czechia
Semmelweis University	Budapest	Hungary
Neuropsychiatrie s.r.o.	Prague	Czechia
NZOZ Wrocławskie Centrum Alzheimerowskie	Wroclaw	Poland
Cdfbdzf Bfpeu Klsnukeqolg Pkxklbep Shy z oolp	Gdansk	Poland
Sydybmk Ukrpdsljlvfbk W Keyxixtv	Cracow	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	16.12.2024
Hungary	Recruiting	16.12.2024
Poland	Recruiting	16.12.2024

Trial locations

Investigated drugs:

(3-BENZYL-3-METHYL-2,3-DIHYDROBENZOFURAN-6- YL)(PIPERIDIN-1-YL)METHANONE

NTRX-07 is a medication being studied for its effects on people with mild cognitive impairment or mild to moderate Alzheimer’s disease. The trial aims to understand how safe and tolerable this medication is when taken over a period of 28 days. Researchers are looking at how the body processes the medication and how it affects the symptoms of Alzheimer’s disease.

Mild Cognitive Impairment (MCI) – MCI is a condition characterized by noticeable changes in cognitive abilities, such as memory and thinking skills, that are greater than expected for a person’s age but not severe enough to interfere significantly with daily life. Individuals with MCI may experience forgetfulness, difficulty in finding words, or challenges in planning and decision-making. The condition can remain stable, improve, or progress to more serious cognitive disorders over time.

Mild to Moderate Alzheimer’s Disease (AD) – Alzheimer’s Disease is a progressive neurological disorder that leads to memory loss, cognitive decline, and changes in behavior. In its mild to moderate stages, individuals may have trouble remembering recent events, managing finances, or performing complex tasks. As the disease progresses, difficulties in language, reasoning, and sensory processing become more pronounced, impacting daily activities and independence.

Trial ID:

2024-517957-29-00

Protocol code:

NTRX-07-C201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of NTRX-07 for Patients with Mild Cognitive Impairment or Mild to Moderate Alzheimer’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?