Study on the Effects of Semaglutide in Patients with Early Alzheimer’s Disease

3 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
KBC Zagreb Zagreb Croatia
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Region Vaesterbotten Umea Sweden
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Amphia Hospital Breda The Netherlands
University Hospital Bratislava Bratislava Slovakia
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
Clinical Research Services Turku CRST Oy Turku Finland
UNIVERZITETNI KLINICNI CENTER MARIBOR Maribor Slovenia
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
Hospital Beatriz Angelo Loures Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
Hospital Universitario Dr Peset Aleixandre Valencia Spain
CRST Helsinki Oy Helsinki Finland
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Henry Dunant Hospital Center Athens Greece
Neuro Health Centrum s.r.o. Brno Czechia
Crystal Comfort s.r.o. Vranov Nad Toplou Slovakia
University Of Eastern Finland Kuopio Finland
AGE Centrum s.r.o. Olomouc Czechia
Centrum Medyczne Senior Sopot Poland
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Fondazione Santa Lucia Rome Italy
CNS Saude Lda. Torres Vedras Portugal
Region Skane Skanes Universitetssjukhus Lund Sweden
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
University Of Debrecen Debrecen Hungary
Clinexpert Kft. Budapest Hungary
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Brain Research Center Den Bosch B.V. s-Hertogenbosch The Netherlands
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Universita’ Politecnica Delle Marche Ancona Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanta Romania
Belvarosi Egeszseghaz Kft. Zalaegerszeg Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
CHC MontLegia Liege Belgium
Centre Hospitalier Universitaire De Nice Nice France
St Vincent’s University Hospital Dublin Ireland
University Medical Center Ljubljana Ljubljana Slovenia
Rigshospitalet Copenhagen Denmark
Poliklinika Solmed d.o.o. Zagreb Croatia
Eginitio Hospital Athens Greece
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Aria Clinic S.R.L. Sibiu Romania
Spitalul Clinic Cai Ferate Constanta Constanta Romania
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Neuroprotect Sp. z o.o. Warsaw Poland
Neuropsychiatrie s.r.o. Prague Czechia
Region Sjaelland Holbæk Denmark
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Sofia Bulgaria
Uniklinikum Salzburg Salzburg Austria
NZOZ Wrocławskie Centrum Alzheimerowskie Wroclaw Poland
Axos sdyiul Prague Czechia
Crhion Hcgffxcuvnq Uymaddbxorgez Rgaij Reims France
Nxydmy scdpgq Krompachy Slovakia
Ppddmlzoxm Klbw Pecs Hungary
Ofcjukv Bgjemkqo Nhvugty Dfwlmfezyeg Cqkvsq Obzcyhixiow Ins Kjmfiyf Hjmmonr Keeosbidx Gvyzwngftmxf Ozstpiz Afumbuaimjfzef Shy z owdo Scinawa Poland
Uzhpjiemef Hycfqxis Cvjtdxb Cologne Germany
Cdvydd Hholtwzxrnz Uducetxkcplij Dz Dfstq Dijon France
Acbacrabij Pspvvjfs Hdwwaljy Dh Mgmreezub Marseille France
Aiqxjj Uvdlacfotx Hylscuub Aarhus Denmark
Akuyqge Odlzukukehu Uoecjpwkgawjz Cageqanfdyjt Dwxsx Suwvqw E Dhpnm Seizmpk Dw Tckilc Turin Italy
Uvapdzhfnpwxxukavsqih Mzjxqffk Ahn Munster Germany
Astunu Metnkil Cpvjiq Srpa Thessaloniki Greece
Hnhqmaba Dl Lj Scucs Chpu I Sjpf Pej Barcelona Spain
Uliwnvrezl Ou Anpysre Edegem Belgium
Iqlthhre Zbjboed Di Bcitpfgmrbvtsdrfa Oświęcim Poland
Uxhhbceutj Gbfldpi Hszdyxtd Axkomrb Athens Greece
Hchiyaza Ueijwcohhofwvi Sovavvglng &ofsehj Hxacfor dz Hxwmquzpabh STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
24.05.2021
Belgium Belgium
Not recruiting
24.05.2021
Bulgaria Bulgaria
Not recruiting
24.05.2021
Croatia Croatia
Not recruiting
24.05.2021
Czechia Czechia
Not recruiting
24.05.2021
Denmark Denmark
Not recruiting
24.05.2021
Finland Finland
Not recruiting
24.05.2021
France France
Not recruiting
24.05.2021
Germany Germany
Not recruiting
24.05.2021
Greece Greece
Not recruiting
24.05.2021
Hungary Hungary
Not recruiting
24.05.2021
Ireland Ireland
Not recruiting
24.05.2021
Italy Italy
Not recruiting
24.05.2021
Poland Poland
Not recruiting
24.05.2021
Portugal Portugal
Not recruiting
24.05.2021
Romania Romania
Not recruiting
24.05.2021
Slovakia Slovakia
Not recruiting
24.05.2021
Slovenia Slovenia
Not recruiting
24.05.2021
Spain Spain
Not recruiting
24.05.2021
Sweden Sweden
Not recruiting
24.05.2021
The Netherlands The Netherlands
Not recruiting
24.05.2021

Trial locations

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.

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 ID:
2023-506918-45-00
Protocol code:
NN6535-4725
NCT ID:
NCT04777409
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of trospium chloride and xanomeline tartrate combination for agitation in Alzheimer’s disease patients: Long-term safety evaluation

    Recruiting

    3 1 1
    Bulgaria Croatia Czechia France Greece Hungary +5
  • A study testing trontinemab compared to placebo in patients with early Alzheimer’s disease including mild cognitive impairment and mild dementia

    Recruiting

    3 1 1
    Denmark France Germany Italy Poland Spain