Not recruitingRare disease

Study on the Effects of Metformin on Cognitive Function in Patients with Huntington'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 metformin on individuals with Huntington's disease. Huntington's disease is a genetic disorder that causes the progressive breakdown of nerve cells in the brain, affecting movement, cognition, and emotions. The study aims to evaluate how metformin, which is known to activate a protein called AMPK, influences cognitive functions in patients with this condition.

Participants in the study will be randomly assigned to receive either metformin or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This approach helps ensure that the results are unbiased. The trial will assess changes in cognitive abilities using specific tests that are sensitive to the progression of Huntington's disease, even in its early stages.

The study will take place over a period of time, during which participants will take the medication orally. The primary focus will be on cognitive tests that measure various aspects of brain function, such as the ability to process information and verbal fluency. These tests are part of a larger scale used to track the progression of Huntington's disease. The goal is to determine if metformin can positively impact these cognitive measures and potentially slow down the progression of the disease.

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, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A series of tests are performed to assess cognitive function, which are part of the Unified Huntington's Disease Rating Scale (UHDRS).
Step 2
Medication administration
Participants are randomly assigned to receive either the study medication, metformin hydrochloride, or a placebo. The medication is provided in the form of 850 mg film-coated tablets.
The tablets are taken orally. The specific dosage and frequency are determined by the study protocol and communicated during the visit.
Step 3
Regular follow-up visits
Regular follow-up visits are scheduled to monitor health and progress. These visits include cognitive assessments and discussions about any side effects or concerns.
The caregiver or family member may be asked to provide additional information during these visits.
Step 4
Final assessment
At the end of the study period, a final assessment is conducted. This includes a comprehensive evaluation of cognitive function using the UHDRS.
The results are used to determine the effect of the medication on cognitive measures of progression in Huntington's disease.

Who can join the trial?

11 criteria

Must have a positive symptomatic clinical diagnosis of Huntington Disease (HD).
Should be able to travel to the study site and likely to continue traveling for the study duration, as judged by the researcher.
A carer, informant, or family member must be available and willing to provide information during study visits. The carer should ideally see the patient at least 2-3 times per week for at least 3 hours each time. The researcher will decide if the carer is suitable.
Must have 36 or more CAG repeats in the huntingtin gene, confirmed by a specific test. CAG repeats are a type of genetic marker related to HD.
Must be a male or female aged between 21-65 years, with HD symptoms starting at age 18 or older.
Women who can have children must use a method of contraception for 30 days before starting the study treatment and use at least two methods of birth control during the study and for 30 days after the last treatment dose.
Must have a score of more than 4 points on the UHDRS-TMS scale and a diagnostic confidence level of 4. The UHDRS-TMS scale is a tool used to measure movement problems in HD.
Must have an Independence scale score of 75% or more. This scale measures how independently a person can live.
Must have a score of 8 or more on the UHDRS-TFC scale at the screening visit. The UHDRS-TFC scale measures the ability to perform daily activities.
Must be able and willing to provide written informed consent before any study-related procedures. If the patient has a legal guardian, they must be authorized according to local requirements.
Must be able and willing to take oral medication and comply with study-specific procedures.

Who cannot join the trial?

3 criteria

Patients who do not have a diagnosis of Huntington Disease.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Verified sites

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Verified
Hospital Universitario Y Politecnico La Fe
Valencia, Spain

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Investigated drugs

Metformin is a medication commonly used to help control blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being studied for its potential effects on brain function in patients with Huntington's disease. Researchers are interested in seeing if metformin can help improve or slow down the decline in cognitive abilities, which are often affected by this disease. The study aims to find out if metformin can positively impact the scores on specific cognitive tests that are sensitive to the progression of Huntington's disease, even in its early stages.

Metformin Hydrochloride

What is already known about the treatment

Metformin – Metformin is taken orally in the form of a tablet and is currently being studied for its potential benefits in treating Huntington's disease, a genetic disorder that affects the brain. It is well-known in medical literature as a medication primarily used to manage type 2 diabetes. The main therapeutic indication in this trial is to assess its impact on cognitive functions in patients with Huntington's disease. At the molecular level, metformin works by activating an enzyme called AMPK, which helps regulate energy balance in cells. It is classified pharmacologically as a biguanide, a type of medication that helps control blood sugar levels.

Investigated diseases

Huntington Disease – Huntington Disease is a genetic disorder that affects the brain, leading to the progressive degeneration of nerve cells. It typically begins with subtle changes in mood, cognition, and motor skills. As the disease progresses, individuals may experience involuntary movements, known as chorea, and difficulties with coordination and balance. Cognitive decline becomes more pronounced, affecting memory, judgment, and the ability to plan and organize. Emotional and behavioral changes, such as depression and irritability, are also common. Over time, these symptoms become more severe, impacting daily functioning and independence.