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Study on the Effects of Semaglutide on Inflammation in Patients with Alzheimer's Disease

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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 medication called semaglutide on people with Alzheimer's disease. Alzheimer's disease is a condition that affects memory and thinking skills, and this study is particularly interested in those with mild cognitive impairment or mild dementia, which are early stages of Alzheimer's. The medication being tested, semaglutide, is given as a solution for injection using a pre-filled pen. The study will compare the effects of semaglutide to a placebo, which is a substance with no active medication.

The purpose of the study is to investigate how semaglutide affects inflammation in the body, both in the brain and in other parts of the body. Inflammation is a response by the body's immune system that can sometimes contribute to diseases like Alzheimer's. Participants in the study will receive injections once a week. The study will last for a period of 65 weeks, during which participants will have regular visits to monitor their health and the effects of the treatment.

Throughout the study, researchers will collect information on any side effects experienced by participants and measure the levels of semaglutide in the body. The study aims to provide insights into whether semaglutide can help reduce inflammation and potentially improve symptoms in people with Alzheimer's disease. This research is important for understanding new ways to manage and treat Alzheimer's disease, which affects many people worldwide.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of mild cognitive impairment or mild dementia of the Alzheimer's type, and amyloid positivity through historical data or a blood sample.
Step 2
Baseline visit
The baseline visit marks the start of the trial, referred to as week 0. During this visit, initial measurements are taken, including gene expression analysis from cerebrospinal fluid and blood samples.
Step 3
Treatment phase
Participants receive a weekly subcutaneous injection of either semaglutide or a placebo. The dosage of semaglutide is 1.0 mg, administered once a week.
The treatment phase continues for a total of 64 weeks, with regular monitoring and assessments throughout this period.
Step 4
Interim assessment
At week 12, an interim assessment is conducted. This includes a repeat of the gene expression analysis to evaluate changes from the baseline.
Step 5
Ongoing monitoring
Throughout the trial, any adverse events are recorded. These are referred to as treatment emergent adverse events (TEAEs).
The average concentration of semaglutide in the body is also monitored from week 4 to the end of the treatment phase.
Step 6
End of treatment
The treatment phase concludes at week 64. Final assessments are conducted to evaluate the overall effects of the treatment on gene expression and any adverse events experienced during the trial.

Who can join the trial?

5 criteria

Must be a male or female aged between 55 and 75 years old at the time of signing the consent form.
Must have Mild Cognitive Impairment (MCI) or mild dementia of the Alzheimer's type. MCI is a condition where a person has slight but noticeable and measurable decline in cognitive abilities, including memory and thinking skills. Dementia is a more severe decline in mental ability that interferes with daily life.
Must have a Clinical Dementia Rating (CDR) global score of 0.5 or 1 at the first screening visit. The CDR is a scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer's disease and related dementias.
Must show amyloid positivity. This can be confirmed through past tests like an amyloid positron emission tomography (PET) scan, which is an imaging test that helps reveal how your tissues and organs are functioning, or a cerebrospinal fluid (CSF) test, which involves collecting fluid from the spine to check for amyloid proteins. Alternatively, a blood test for amyloid biomarkers can be done at the first screening visit.
Must be treated with acetylcholinesterase inhibitors, which are medications approved for treating Alzheimer's disease, and must have been on a stable dose for more than 90 days before the first screening visit.

Who cannot join the trial?

1 criterion

Individuals who do not have mild cognitive impairment (MCI) or mild dementia of the Alzheimer’s type cannot participate. MCI is a condition where a person has slight but noticeable and measurable decline in cognitive abilities, including memory and thinking skills. Dementia is a more severe decline in mental ability that interferes with daily life.

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Verified sites

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Karolinska University Hospital
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Solna, Sweden
Rigshospitalet
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Copenhagen, Denmark

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Investigated drugs

Semaglutide is a medication being studied for its potential effects on inflammation in the brain and body in people with Alzheimer's disease. It is given as an injection under the skin once a week. The study aims to see if semaglutide can help reduce inflammation, which is thought to play a role in Alzheimer's disease.

Semaglutide

What is already known about the treatment

Semaglutide – This medication is administered as a subcutaneous injection, typically given once a week. It is currently being studied in clinical trials for its potential effects on inflammation in patients with Alzheimer's disease, specifically those with mild cognitive impairment or mild dementia. Semaglutide is primarily used for its role in managing blood sugar levels in type 2 diabetes, but its anti-inflammatory properties are being explored for Alzheimer's. It works by mimicking a hormone called GLP-1, which increases insulin secretion and reduces glucagon release, thereby lowering blood sugar levels. Semaglutide is classified as a GLP-1 receptor agonist.

Investigated diseases

Mild Cognitive Impairment (MCI)
This condition involves a noticeable decline in cognitive abilities, such as memory and thinking skills, that is greater than expected for a person's age but not severe enough to interfere significantly with daily life. Individuals with MCI may experience forgetfulness, difficulty in finding words, or challenges in making decisions. The progression of MCI can vary, with some individuals remaining stable or even improving, while others may progress to more severe forms of cognitive decline, such as dementia.
Mild Dementia of the Alzheimer’s Type
This is an early stage of Alzheimer's disease characterized by mild but noticeable changes in memory and thinking abilities. Individuals may have trouble remembering recent events, managing finances, or following conversations. As the disease progresses, these cognitive difficulties become more pronounced, affecting daily activities and social interactions. The progression is gradual, with symptoms worsening over time, leading to increased dependency on others for assistance.