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Study on the Effects of Semaglutide in Patients with Early 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 and safety of a medication called semaglutide in people with early stages of Alzheimer's disease. Alzheimer's disease is a condition that affects memory and thinking skills. The study involves participants who have mild cognitive impairment or mild dementia, both of which are early forms of Alzheimer's disease. The medication being tested is in the form of tablets, known as Rybelsus, which come in different strengths: 3 mg, 7 mg, and 14 mg. Some participants will receive these tablets, while others will receive a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine if semaglutide can improve cognition, which includes memory and thinking abilities, and daily functioning in people with early Alzheimer's disease. Participants will take the medication or placebo orally, meaning by mouth, over a period of time. The study will monitor changes in their cognitive abilities and daily activities to see if there is any improvement. The trial is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will be regularly assessed to track any changes in their condition. The main focus will be on changes in a specific score that measures dementia symptoms, known as the Clinical Dementia Rating – Sum of Boxes (CDR-SB). Additionally, the study will look at how participants manage daily activities and whether there is any progression to more severe dementia. The trial is expected to continue for a set period, with regular check-ins to evaluate the effects of the treatment.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes evaluating cognitive function and daily living activities.

    Eligibility criteria include being aged 55-85 years, having mild cognitive impairment or mild dementia of the Alzheimer's type, and meeting specific cognitive test scores.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to establish a starting point for the study. This includes cognitive tests and assessments of daily living activities.

    The Clinical Dementia Rating – Sum of Boxes (CDR-SB) score is recorded, which ranges from 0 to 18.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either oral semaglutide or a placebo. The medications are administered in tablet form.

    The dosages include Rybelsus 3 mg, 7 mg, or 14 mg tablets, taken orally. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Ongoing assessments

    Throughout the study, regular assessments are conducted to monitor changes in cognition and daily functioning.

    The primary endpoint is the change in the CDR-SB score from baseline to week 104.

  5. Step 5

    Final evaluation

    At the end of the study period, a final evaluation is conducted to assess the overall impact of the medication on cognitive function and daily activities.

    Secondary endpoints include changes in the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for MCI and the time to progression to dementia.

Who can join the trial?

8 criteria

  • Must be a male or female aged between 55 and 85 years old.
  • Must have **mild cognitive impairment (MCI)** or **mild dementia** of the **Alzheimer's type**. These are conditions where memory and thinking skills are affected.
  • Must have a **CDR global score** of 0.5 or 1.0. The **CDR** (Clinical Dementia Rating) is a scale used to measure the severity of dementia symptoms.
  • Must have a score of 0.5 or more in at least one of the three categories of daily activities: personal care, home & hobbies, or community affairs.
  • Must have an **RBANS delayed memory index score** of 85 or lower. This score measures memory abilities.
  • Must have an **MMSE score** of 22 or higher. The **MMSE** (Mini-Mental State Examination) is a test that checks mental functions like memory and attention.
  • Must show **amyloid positivity**. This means having certain proteins in the brain, which can be checked using a scan called **amyloid PET** or a test of the fluid around the brain called **CSF**.
  • If taking any approved Alzheimer's disease treatments, such as certain medications, the dose must have been stable for at least 3 months before starting the trial and should not change during the trial unless necessary for health reasons.

Who cannot join the trial?

4 criteria

  • Individuals who do not have mild cognitive impairment (MCI) or mild dementia of the Alzheimer’s type cannot participate. MCI is a condition where someone has slight but noticeable and measurable decline in cognitive abilities, including memory and thinking skills. Mild dementia is a stage where there is more significant decline in memory and thinking, but the person can still perform daily activities.
  • Participants must be within a certain age range, typically older adults, to be eligible.
  • Both men and women can participate, but they must meet all other criteria.
  • Individuals who are considered part of a vulnerable population, meaning they might have additional risks or challenges, may not be eligible.
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Investigated drugs

Semaglutide: This medication is being tested to see if it can help improve cognition and function in people with early Alzheimer's disease. It is taken orally and is being compared to a placebo to determine its effectiveness and safety in treating mild cognitive impairment or mild dementia associated with Alzheimer's.

What is already known about the treatment

Semaglutide – This medication is administered orally and is currently being studied in clinical trials for its potential benefits in treating early Alzheimer's disease, specifically in individuals with mild cognitive impairment or mild dementia of the Alzheimer's type. Semaglutide is primarily known as a treatment for type 2 diabetes, but its role in Alzheimer's is under investigation. It works by mimicking a hormone in the body that helps regulate blood sugar levels and may have effects on brain function. Semaglutide belongs to the pharmacological class of GLP-1 receptor agonists.

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 trouble with complex tasks. 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, thinking, and reasoning. 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.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506918-45-00Protocol codeNN6535-4725Estimated enrolment1 953 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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