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Study on Choline Alfoscerate for Patients with Mild Cognitive Impairment

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for individuals experiencing mild cognitive dysfunction, which is a condition that affects memory and thinking skills. The treatment being tested is a medication called Choline Alfoscerate, which is a type of cholinergic precursor. This means it helps increase the levels of a chemical in the brain that is important for memory and learning.

The purpose of the study is to see if Choline Alfoscerate can slow down or stabilize changes in certain areas of the brain, such as the hippocampus, which is involved in memory. The study will also look at whether the treatment can help maintain or improve cognitive abilities, like memory and attention, by using special tests to measure these skills. Participants will take the medication as an oral solution, which means it is taken by mouth.

Throughout the study, participants will undergo assessments to monitor any changes in their brain structure and cognitive performance. These assessments will include imaging techniques like MRI to observe the brain and neuropsychological tests to evaluate cognitive functions. The study aims to provide insights into how Choline Alfoscerate might benefit those with mild cognitive dysfunction, especially when there is associated vascular damage, which refers to issues with blood vessels that can affect brain health.

1 initial assessment

The initial assessment involves a review of memory disorders using neuropsychological testing. This includes the Mini Mental State Evaluation (MMSE) and the Clinical Dementia Rating (CDR).

An MRI scan must have been performed within six months prior to joining the study to assess brain structure.

2 medication administration

The medication used in this study is choline alfoscerate, administered as an oral solution under the product name GLIATILIN 600 mg flaconcini.

The dosage and frequency of administration will be determined by the study protocol and communicated to the patient at the start of the trial.

3 ongoing monitoring

Regular monitoring will be conducted to evaluate the effects of the medication on brain structure and cognitive abilities.

This includes assessments of hippocampal atrophy, entorhinal cortex, neocortex, and ventricular dilation using MRI imaging.

4 cognitive evaluation

Cognitive abilities will be assessed using neuropsychological scales to evaluate executive, memory, visual-constructive, linguistic, and attentional functions.

Functional performance, mood, and motivation will also be evaluated through specific tests.

5 completion of study

The study is estimated to conclude by June 30, 2025.

At the end of the study, a final evaluation will compare cognitive performance and brain structure from the beginning to the end of the trial.

Who Can Join the Study?

  • The patient must be able to understand and sign an informed consent form, and a family member or caregiver must also sign it.
  • The patient must be at least 65 years old.
  • The patient must have memory problems, which will be checked using special tests called Neuropsychological Testing. These include:
    • Mini Mental State Evaluation (MMSE): The patient must score 24.
    • Clinical Dementia Rating (CDR): The patient must have a score of 0.5.
  • The patient must have enough education to read, write, and communicate effectively.
  • The patient must be independent in daily, family, work, and social activities.
  • The patient must be cooperative and able to complete all parts of the study, either alone or with help from a family member.
  • The patient must live with or be in contact with a family member or caregiver who can help evaluate the study’s effectiveness.
  • The patient must have had an MRI (a type of brain scan) within six months before joining the study.
  • The patient must have at least two of the following vascular risk factors:
    • High blood pressure (systemic arterial hypertension)
    • Diabetes
    • Obesity
    • Heart disease, such as irregular heartbeat (atrial fibrillation)
    • High cholesterol or other blood fat issues (dyslipidaemia)
    • High levels of a substance called homocysteine in the blood (hyperhomocysteinemia)
    • Smoking (tobacco addiction)
    • Previous stroke or other blood flow problems in the brain (cerebrovascular events)
    • Family history of heart or brain blood flow diseases (cardio-cerebrovascular diseases)

Who Cannot Join the Study?

  • Patients with severe cognitive dysfunction cannot participate. This means if the memory or thinking problems are more than mild, the patient is not eligible.
  • Patients with other serious neurological disorders are excluded. Neurological disorders are problems with the brain, spinal cord, or nerves.
  • Patients with severe psychiatric disorders cannot join. Psychiatric disorders are mental health issues like severe depression or schizophrenia.
  • Patients with uncontrolled medical conditions are not allowed. This means if a patient has a health problem that is not being managed well, they cannot participate.
  • Patients who are pregnant or breastfeeding are excluded. This is to ensure the safety of both the mother and the baby.
  • Patients who are participating in another clinical trial cannot join. This is to avoid any interference with the study results.
  • Patients with a history of drug or alcohol abuse are not eligible. This is because substance abuse can affect the study outcomes.
  • Patients who have had a recent stroke are excluded. A stroke is when blood flow to a part of the brain is stopped, causing brain damage.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
15.04.2022

Trial locations

Investigated drugs:

Choline Alfoscerate is a medication used in this study to help with mild cognitive dysfunction. It is a cholinergic precursor, which means it helps increase the levels of a chemical in the brain called acetylcholine. This chemical is important for memory and learning. The study aims to see if this medication can slow down or stabilize changes in certain parts of the brain, such as the hippocampus and cortex, which are involved in memory and thinking.

Mild Cognitive Dysfunction – This condition involves a noticeable decline in cognitive abilities, such as memory and thinking skills, which is greater than expected for a person’s age but does not interfere significantly with daily life. It may include difficulties with memory, language, thinking, and judgment. The progression can vary, with some individuals experiencing a stable condition while others may see a gradual worsening of symptoms. It is often associated with vascular damage, which can affect blood flow to the brain and contribute to cognitive decline. The condition is typically identified through cognitive assessments and imaging studies that may show changes in brain structure.

Trial ID:
2025-520685-21-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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