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Study on the Effects of Lamivudine on Cognitive Impairment in Patients with Mild Cognitive Impairment Due to Alzheimer's Disease

Verified siteRegistered 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 the medication lamivudine on patients with Mild Cognitive Impairment (MCI), which is often an early stage of Alzheimer's Disease. MCI involves changes in thinking, learning, and memory that are more significant than typical age-related changes but not severe enough to interfere significantly with daily life. The purpose of the study is to evaluate how lamivudine affects certain biological markers related to cognitive impairment and immune system activity in the blood of these patients.

Participants in the study will take lamivudine in the form of a film-coated tablet. The study will last for 24 weeks, during which time participants will be monitored for changes in specific markers in their blood. These markers include proteins and genes that are associated with cognitive function and the body's immune response. The study will also track any side effects that may occur during the treatment period.

Throughout the study, participants will have regular visits to the study center to undergo various tests and assessments. These visits are designed to monitor the effects of the treatment on their cognitive abilities and overall health. The study aims to provide valuable insights into the potential benefits of lamivudine for individuals with MCI due to 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
During the initial visit, the participant will undergo a series of assessments to confirm eligibility for the study. This includes reviewing medical history and current medications.
The participant will be informed about the study procedures and will provide written consent to participate.
Step 2
Baseline Assessment
The participant will undergo cognitive and functional tests to establish a baseline for comparison throughout the study.
Blood samples will be collected to measure levels of specific biomarkers related to cognitive impairment.
Step 3
Medication Administration
The participant will begin taking lamivudine, a medication in the form of a 300 mg film-coated tablet, administered orally.
The medication will be taken once daily for a period of 24 weeks.
Step 4
Regular Monitoring
Throughout the 24-week treatment period, the participant will attend regular visits to monitor health and any potential side effects.
Blood samples will be collected periodically to assess changes in biomarkers and gene expression.
Step 5
Final Assessment
At the end of the 24-week period, the participant will undergo a final assessment similar to the baseline assessment.
The results will be compared to the baseline to evaluate the effect of the medication on cognitive impairment.

Who can join the trial?

12 criteria

Participants must be between 55 and 90 years old.
Participants must have a diagnosis of **Mild Cognitive Impairment (MCI)** due to **Alzheimer's Disease (AD)**, confirmed by a healthcare professional.
Participants must have a **Clinical Dementia Rating (CDR)**-Global Score of 0.5, which is a way to measure the level of dementia.
Participants must have had imaging tests like **MRI** or **CT** scans within the last 2 years to rule out other causes of dementia.
Participants must have a confirmed AD diagnosis through tests like **CSF** (cerebrospinal fluid) analysis or **amyloid-PET** imaging, which check for specific markers of Alzheimer's.
If participants are taking approved medications for AD, they must have been on a stable dose for at least 4 weeks before the study starts.
If participants are taking over-the-counter supplements for brain health, they must not exceed the recommended dose and must have been on a stable dose for at least 4 weeks before the study starts.
Participants must be able to visit the study center and complete various tests as part of the study.
If a caregiver is needed, the caregiver must agree to accompany the participant to all study visits, help with study procedures, and provide information about the participant. The caregiver should have regular contact with the participant and be able to communicate effectively in the study's language.
Male participants must agree to use effective birth control during the study and for 3 months after the last dose, and must not donate sperm during this time.
Female participants must not be pregnant or breastfeeding and must agree to use effective birth control if they are of childbearing potential.
Participants and their caregivers must provide written informed consent before starting any study-related procedures.

Who cannot join the trial?

7 criteria

Patients who do not have Mild Cognitive Impairment due to Alzheimer's Disease. This means if you have memory problems not related to Alzheimer's, you cannot participate.
Patients who are not within the specified age range. The study is looking for participants in certain age groups, so if you are too young or too old, you may not be eligible.
Patients who are not willing to follow the study procedures. This means if you cannot or do not want to follow the rules and steps of the study, you cannot join.
Patients who have other medical conditions that might interfere with the study. If you have other health issues that could affect the study results, you may not be able to participate.
Patients who are taking medications that might interfere with the study. If you are on certain drugs that could change the study outcomes, you might be excluded.
Patients who are pregnant or breastfeeding. If you are expecting a baby or nursing, you cannot take part in the study.
Patients who have participated in another clinical trial recently. If you have been part of another study in the recent past, you may not be eligible for this one.

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Verified sites

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Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
Verified
Badalona, Spain

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Investigated drugs

Lamivudine is a medication being studied for its potential to reduce certain biomarkers related to neurocognitive impairment and type-I interferon-stimulated genes in patients with Mild Cognitive Impairment (MCI). The trial aims to see if taking lamivudine for 24 weeks can lower these biomarkers in the blood of patients who also have positive Alzheimer's Disease (AD) biomarkers. The study also looks at any side effects that might occur during the treatment.

Lamivudine

What is already known about the treatment

Lamivudine – Lamivudine is typically administered orally in tablet form. It is currently being studied in clinical trials for its potential effects on neurocognitive impairment in patients with mild cognitive impairment due to Alzheimer's disease. The main therapeutic indication being explored is its ability to reduce biomarkers associated with neurocognitive impairment and type-I interferon-stimulated genes. At the molecular level, lamivudine works by inhibiting the reverse transcriptase enzyme, which is crucial for viral replication, although its exact mechanism in neurocognitive conditions is still under investigation. It is classified pharmacologically as a nucleoside reverse transcriptase inhibitor (NRTI).

Investigated diseases

Mild Cognitive Impairment due to Alzheimer's Disease – This condition is characterized by a noticeable decline in cognitive abilities, such as memory and thinking skills, which is greater than expected for a person's age but not severe enough to interfere significantly with daily life. It is considered an early stage of Alzheimer's Disease, where individuals may experience forgetfulness, difficulty in finding words, or trouble with complex tasks. As the condition progresses, these cognitive challenges may become more pronounced, potentially leading to a diagnosis of Alzheimer's Disease. The progression can vary among individuals, with some maintaining stable symptoms for years, while others may experience a gradual worsening of cognitive functions.