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

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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
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Ospedale San Raffaele S.r.l. Milan Italy
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Amphia Hospital Breda The Netherlands
Clinexpert Kft. Budapest Hungary
University Medical Center Ljubljana Ljubljana Slovenia
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
University Of Eastern Finland Kuopio Finland
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
AGE Centrum s.r.o. Olomouc Czechia
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
NZOZ Wrocławskie Centrum Alzheimerowskie Wroclaw Poland
Hwsvrugd Udxvrwdcloyj Gkejajh Dl Cluqrxnlo Sant Cugat Del Valles Spain
Ujyhentybg Ok Dwthtchz Debrecen Hungary
Uerchdjhzq Ggojpzy Hfvbiflb Oh Tvajdnnpyclr Aesmq Thessaloniki Greece
Uofkzzpkzdl nslvvinsz Lq Pltlmghj Kkozzk Kosice Slovakia
Dfbblwzrwypotavuzdtrziu cyprgm “mclzdppppzxyttj Eqff Sofia Bulgaria
Rybhvm Sdepyjmqe Holbæk Denmark
Umocjeqrzj Hsdvrybt Cofnkiq Cologne Germany
Fdsofesqgn Isexn Ck Gdlwkp Obqyepng Mwvmsmlr Pzpveuzrhaq Milan Italy
Arcrtcfcmt Pnygpefn Hqmjprmp Dg Minfcmlqh Marseille France
Rqfrwa Sqgrf Skohnn Uhvijbppqrjwgztling Lund Sweden
Slygxzhyu Rcytrqr Upmpemgebg Mbrqrpt Cjlarf Nijmegen The Netherlands
Uysrplixqrzfcdjxh Pycmlbhycob Dcnkx Mkbykd Ancona Italy
Sdxmwacojzr Pwrxoapot Zomhet Ocnsfp Zqecafnxqw Sbeyhpa Uehchixzoxhlf W Knsostwo Cracow Poland
Apqigoz Ohsieltitiv Ujhjlpuybsbmk Cgxbftoekvsk Duejt Svvdhr E Dbrhh Sdwzefy Dd Tygrjh Turin Italy
Uqlrtewwjzpazglepbcka Mujapqsv Asr Munster Germany
Ahnmzr Mtflvbs Ckbbpr Szqz Thessaloniki Greece
Rmzqkbhllgxjqc Copenhagen Denmark
Pbjdocnqkdw Shgkod dfnunr Zagreb Croatia
Csplfl Hyjledlnkz Uteqwirhkmhlu Df Sfopc Aqrpuxi Eyxgmv Porto Portugal
Hvwbcidd Dg Lj Spvyk Cqmx I Sqru Pwz Barcelona Spain
Udapxtmojy Ot Awxuoje Edegem Belgium
Uxfokampxjbt Ztcvcoduar Gfks Gent Belgium
Ccbhuw Hcvjmjankll Lfrc Stb Pierre Benite France
Hjpzcpmy Ujihlhcvvqyrl 1o Dq Oawanpg Madrid Spain
Uxvmwtdmnh Duita Stbeg Dz Bfjnnwf Brescia Italy
Atkihfyz Zqqstchdsq Ghoxngzlx Kortrijk Belgium
Cixx Cagwvn Chclwls Afxigwtig Bpkwx Aegqkpkfhe Braga Portugal
Finzwwievq Ifiug Srb Gjlhxzj Djg Tyabogc Monza Italy
Hgzyfzfb Uxbswfhthafvby Swzooozegf &xiatcz Hliqixt dr Hgypzoshykl STRASBOURG, Alsace France
Uwdjxtcurmj Sdxprsoc Salzburg Austria
Kdc Zknxnb Zagreb Croatia
Puvwvqrfyt Kefn Pecs Hungary
Mluwmwabratv Hfohbosc Fvi Ahnllt Trhkfzgkn Ij Nsngvlelt Amm Paqqdxacne Szi Njng Ett Sofia Bulgaria
Ujihcyehuy dsfiw svzet Gklwlmvi Dkhtugozhx Cnrlywuczvarkr Csdbch dg Smwwn e toknfwjggv aszhiput Chieti Italy
Bwosd Rqaeyhof Cbgnwr Dzj Brtxb Bwij S-Hertogenbosch The Netherlands
Nqftwbcnmuiquywu sebtal Prague Czechia
Akpk sdperv Prague Czechia
Osgccnd Bkygatky Nkplkhn Dqzftcvyevy Cjlwtw Owqamkbizal Ita Kyotqcw Hfzkdkf Kivqnxiej Gdkpcsjdfqyv Olcbrvh Akdzhnehyjefja Sry z ohkz Scinawa Poland
Nsegk Hogcmj Chbycqt sarnbz Brno Czechia
Nzzjye scyfpv Krompachy Slovakia
Iujwibum Zxwqdyb Dq Boeurazxttdbvsdwk Oświęcim Poland
Dastlbtuza Azs Cinjaexvregh Cehicq Ssbtqexj Ajs Sobzcs Kzcdn Azo Dnmhwt Opt Sofia Bulgaria
Cfkpfw Hapeifgvbtu Uksamezphssby Dw Daptd Dijon France
Uavyquffydniqsfsp Cndxtn Bfbbsydrgm Dh Rgpy Rome Italy
Ajpimv Ulcsdddagr Hvkqwdya Aarhus Denmark
Huisjedf Uyqyjfirdsxrs Qzqccjtjsyw Mfsisv Pozuelo De Alarcon Spain
Smfvxtjy Cekiot Jsnbftea Dn Udjmeek Sbhdvxs Axkljpv Azlbxa Cixwxvsay Constanta Romania
Btopudgfb Exriayxcdtc Kglk Zalaegerszeg Hungary
Vahllb Ccqcaex smnjps Rychnov Nad Kneznou Czechia
Cyl Muvhblbki Liege Belgium
Sn Vtmhbatucnfzibj Usbnaehfvo Hwkcxrpb Dublin Ireland
Erizgwwe Hmqogypc Athens Greece
Avyo Clxqng Scpvqq Sibiu Romania
Slnvptaa Caybuj Cwr Fpohro Cpzkdjmru Constanta Romania
Cyprkx Hgfwdyoaqde Uzbptcyiwmggo Rpkww Reims France
Rgztvp Vbqptgvsrpayo Umea Sweden
Hifitzne Sweub Mmfpy Dguaa Mhmvyorgynjc Perugia Italy
Ukfwwrrqvf Hdgwuklo Bffveaexld Bratislava Slovakia
Eanltufwng Gsnlwoa Crhjxr Oe Tdbwuxinqxib Thessaloniki Greece
Cfrjjapg Rjxewjag Siuyoqqo Tlbqo Cojb Op Turku Finland
Uouxvxfhnynqd Kzuccbat Cnbkhv Mtasmio Maribor Slovenia
Hlfclbev Bxhfrsj Atcyhs Loures Portugal
Hgsjmtkh Usobodcynmmac Dz Pvljb Alliwdxkum Valencia Spain
Cpdq Hxmkzikv Ox Helsinki Finland
Cgigqmn Msqxpvgi Ndqkjmhk Slv z ojyy Bydgoszcz Poland
Uryboqp Lswxa Db Sipvd Dj Mhofnzmpes Emhkva Senhora Da Hora Portugal
Croyvdv Mbagibbz Srmwon Sopot Poland
Cbh Svdmm Lmmd Torres Vedras Portugal
Hhdrd Dsnwfu Hkqbgmor Cnvboe Athens Greece
Cytqdts Ccvwktc sxbsdy Vranov Nad Toplou Slovakia
Fgbicmzbud Sxcon Lvydd Rome Italy
Niknhhhoiejh Slt z ocvk Warsaw Poland
Crwmya Hhharhfyoo E Udieyrqyisdoj Du Ctzttff Eaqyxb Coimbra Portugal
Uqfjkcryuk Gcqsftc Hfsbngnr Afpqszh Glzalfs Hpzqqunn Ot Wvet Avtepn H Awop Vcjayxf Chaidari Greece

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.

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

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