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Study on Efavirenz for Patients with Early Alzheimer's Disease

Investigational

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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 Alzheimer's Disease, a condition that affects memory and thinking skills. The trial will evaluate the effects of a medication called Efavirenz, which is taken in tablet form. The purpose of the study is to understand how Efavirenz works in the body and its safety for patients with early stages of Alzheimer's Disease.

Participants in the study will be randomly assigned to receive either Efavirenz or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment.

The study will last for several months, during which participants will take the medication or placebo and attend regular check-ups. These visits will help monitor the effects of the treatment on the body, including changes in certain substances in the brain and blood that are related to Alzheimer's Disease. The goal is to gather information that could lead to better treatments for this condition in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, the initial visit involves a comprehensive assessment to confirm eligibility. This includes a review of medical history and a series of tests to establish a baseline for Alzheimer's disease markers.
The patient will undergo a mini-mental state examination (MMSE) to assess cognitive function, and a clinical dementia rating (CDR) to determine the stage of Alzheimer's disease.
Step 2
Randomization and medication
Participants are randomly assigned to receive either Efavirenz or a placebo. This process is double-blinded, meaning neither the patient nor the study team knows which treatment is being administered.
The medication is taken orally in tablet form. The dosage and frequency are determined by the study protocol, and the treatment continues for the duration of the study.
Step 3
Follow-up visits
Regular follow-up visits are scheduled to monitor the patient's health and response to the medication. These visits include physical examinations and cognitive assessments.
Blood and cerebrospinal fluid (CSF) samples are collected at specified intervals to measure levels of 24-hydroxycholesterol and other Alzheimer's disease biomarkers.
Step 4
End of treatment
At the end of the treatment period, a final assessment is conducted to evaluate changes in Alzheimer's disease markers and overall health.
The study aims to determine the effect of Efavirenz on Alzheimer's disease progression by comparing the baseline and end-of-study results.

Who can join the trial?

7 criteria

Age must be between 50 and 75 years at the time of the Screening Visit.
Participants can be males or females who are post-menopausal or cannot have children.
Must have a diagnosis of Alzheimer's Disease (AD) based on specific criteria, which include certain levels of proteins in the cerebrospinal fluid (CSF) or a special brain scan called amyloid PET scan done in the last 12 months.
Must be in AD Clinical Stage 3 or 4, which means having a mini-mental state examination (MMSE) score of 20 or higher and a Clinical Dementia Rating (CDR) global score between 0.5 and 1.0.
Must be able to speak, read, and write the local language fluently.
Participants should either not be on any approved treatments for AD or be on a stable dose of medication for at least 3 months before starting the study.
Both the patient and their care partner must agree to all study procedures.

Who cannot join the trial?

10 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who are unable to follow the study procedures or instructions.
Patients who have participated in another clinical trial recently.
Patients who are pregnant or breastfeeding.
Patients with a history of allergic reactions to similar medications.
Patients with severe liver or kidney problems.
Patients with a history of drug or alcohol abuse.
Patients who are taking medications that might interfere with the study drug.
Patients with a history of certain mental health conditions.
Patients who have had a major surgery recently.

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Investigated drugs

Efavirenz is a medication being studied for its potential effects on patients with early Alzheimer's Disease. In this trial, researchers are examining how the drug affects certain cholesterol levels in the brain over a period of time. The goal is to understand if Efavirenz can influence these levels and potentially offer a new treatment option for Alzheimer's Disease.

Efavirenz

What is already known about the treatment

Efavirenz – Efavirenz is administered orally, typically in tablet form. It is currently being studied in clinical trials for its potential use in treating early Alzheimer's Disease. The main therapeutic indication being explored is its effect on Alzheimer's, specifically looking at changes in cholesterol levels in the brain. At the molecular level, Efavirenz is known to inhibit certain enzymes, which may influence cholesterol metabolism in the brain. It is pharmacologically classified as a non-nucleoside reverse transcriptase inhibitor, originally used in the treatment of HIV.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration of brain cells, resulting in memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, gradually worsening over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. Eventually, it can impair the ability to carry out daily activities and recognize familiar people. The exact cause is not fully understood, but it involves a combination of genetic, environmental, and lifestyle factors. Alzheimer's Disease is the most common cause of dementia among older adults.