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Study on the Effectiveness of Choline Alfoscerate for Treating Mild Depression in Elderly Patients

Registered drugNo placebo
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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 treatment for a condition known as subthreshold depression in older adults. Subthreshold depression refers to having some symptoms of depression, but not enough to be diagnosed with major depression. The treatment being tested is a medication called choline alfoscerate, which is taken in the form of a soft capsule known as GLIATILIN 600. This medication is being evaluated to see if it can help improve the symptoms of depression in elderly patients.

The purpose of the study is to assess how effective choline alfoscerate is in treating subthreshold depression in people aged 65 and older. Participants in the study will take the medication orally, and the study will last for a period of up to eight weeks. During this time, the effects of the medication on depression symptoms will be monitored and evaluated. The study aims to provide insights into whether this treatment can be beneficial for older adults experiencing mild depression symptoms.

Throughout the study, participants will undergo various assessments to track changes in their depression symptoms. These assessments will help determine if there is an improvement in their condition after taking the medication. The study is designed to gather important information that could lead to better treatment options for elderly individuals with subthreshold depression.

The research process

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

  1. Step 1

    Enrollment

    The study involves individuals aged 65 years or older who have experienced 2 to 4 depressive symptoms for at least two weeks before joining the study.

    Participants must have a Mini-Mental State Examination (MMSE) score of 24 or higher and a Montreal Cognitive Assessment (MOCA) score of less than 26.

    Participants must be able to understand and sign an informed consent form.

  2. Step 2

    Baseline assessment

    Initial assessments are conducted to establish a baseline for depression and cognitive symptoms.

    The Hamilton Depression Rating Scale (HAMD-17) is used to evaluate depression symptoms.

    The Geriatric Depression Scale (GDS-15) and Clinical Global Impression-severity (CGI-s) are also used to assess depression symptoms.

    The Montreal Cognitive Assessment (MOCA) scale is used to evaluate cognitive symptoms.

  3. Step 3

    Medication administration

    Participants receive choline alfoscerate in the form of GLIATILIN 600 capsule.

    The medication is administered orally as a soft capsule.

    The dosage and frequency of administration are determined by the study protocol.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor changes in depression and cognitive symptoms.

    The same scales used in the baseline assessment (HAMD-17, GDS-15, CGI-s, and MOCA) are used to evaluate changes from the baseline.

  5. Step 5

    Final assessment

    At the end of the study, a final assessment is conducted to evaluate the effectiveness of the treatment.

    Changes in depression and cognitive symptoms from the baseline are analyzed using the same scales.

Who can join the trial?

6 criteria

  • Must be **65 years** or older.
  • Have **2 to 4 depressive symptoms** that have been present for at least two weeks before joining the study. Depressive symptoms can include feelings of sadness, loss of interest in activities, or changes in sleep or appetite.
  • Have a **Mini-Mental State Examination (MMSE) score of 24 or higher**. This is a test that checks memory and thinking skills.
  • Have a **Montreal Cognitive Assessment (MOCA) score of less than 26**. This is another test that checks thinking skills, like memory and attention.
  • Must be able to understand the study and sign a form agreeing to participate, known as **informed consent**.
  • Must have signed the **informed consent** form.

Who cannot join the trial?

3 criteria

  • Patients who are not elderly. This study is specifically for older adults.
  • Patients who do not have **subthreshold depression**. This means the depression is not severe enough to meet the full criteria for a major depressive disorder but still affects the person.
  • Patients who are part of a **vulnerable population**. This refers to groups of people who might be at a higher risk of harm or exploitation, such as children or those unable to give consent.
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Investigated drugs

Choline Alfoscerate is being studied for its potential effectiveness in treating subthreshold depression in elderly patients. This medication is thought to help improve mood and cognitive function by increasing the levels of a chemical in the brain that is important for memory and learning. The study aims to determine if this medication can provide relief from depressive symptoms in older adults who do not meet the full criteria for major depression.

What is already known about the treatment

Choline Alfoscerate – This medication is administered orally and is currently being studied for its effectiveness in treating subthreshold depression in elderly patients. It is in the clinical trial phase, with ongoing research to establish its efficacy and safety. The main therapeutic indication is for mood improvement in older adults experiencing mild depressive symptoms. At the molecular level, choline alfoscerate works by increasing the levels of acetylcholine, a neurotransmitter important for brain function, which may help improve mood and cognitive function. It is classified pharmacologically as a cholinergic agent.

Investigated diseases

Subthreshold Depression in the Elderly – This condition is characterized by depressive symptoms that do not meet the full criteria for major depressive disorder. It often includes feelings of sadness, lack of interest in activities, and low energy. In elderly individuals, it may also manifest as cognitive difficulties, such as problems with memory and concentration. The symptoms can fluctuate in intensity and may be influenced by social and environmental factors. Over time, these symptoms can impact daily functioning and quality of life. The condition is often assessed using scales like the Hamilton Depression Rating Scale and the Geriatric Depression Scale.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520899-25-00Protocol codeCARTESIOEstimated enrolment20 patientsSponsorAzienda Socio Sanitaria Territoriale Di Lodi

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