Une étude randomisée à double insu et contrôlée par placebo examinant les effets et l’innocuité de l’administration de sémaglutide par voie orale chez des sujets en phase initiale de la maladie d’alzheimer (evoke)
Promoteur(s) :
Novo Nordisk
Recrutement : fermé
Centres participants
1
0
Dernière modification : 2026-02-11
DESCRIPTION DE L'ÉTUDE
Résumé de l'étude
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.
Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.
The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.
Participants must have a study partner, who is willing to take part in the study.
Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.
A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.
Source : Importé depuis le centre
RECRUTEMENT
Profil des participants
Sexe(s) des participants
Hommes
Femmes
Aptitude des participants
Majeurs aptes
Majeurs, mais dont l'inaptitude est subite
Condition médicale (spécialité visée)
Donnée non disponible
Critères de sélection
Critères d'inclusion
-Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
-MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria.
-CDR (Clinical Dementia Rating) global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home & hobbies, community affairs) Or CDR global score of 1.0
-RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index score of below or equal to 85
-MMSE (Mini-Mental State Examination) greater than or equal to 22
-Amyloid positivity established with either amyloid PET (positron emission tomography), CSF (cerebrospinal fluid) Aβ1-42 or CSF Aβ1-42/Aβ1-40 .
-If receiving an approved Alzheimer's disease treatment (such as acetylcholinesterase inhibitors, memantine or aducanumab) the dose must have been stable for at least 3 months prior to screening and should not be changed during the trial unless medically necessary.
Source : Importé depuis le centre
Critères d'exclusion
-Brain MRI (or CT) scan suggestive of clinically significant structural CNS disease confirmed by central read (e.g. cerebral large-vessel disease [large vessel (cortical) infarcts greater than 10 mm in diameter], prior macro-haemorrhage [greater than 1 cm^3], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus).
-Brain MRI (magnetic resonance imaging) (or CT) scan suggestive of significant small vessel pathology confirmed by central read and defined as greater than1 lacunar infarct and/or ARWMC (age-related white matter changes) greater than 2, (WM (white matter) greater than 20 mm) in the deep white matter and periventricular regions.
-Brain MRI (or CT) scan suggestive of strategic infarcts defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed by central read.
-Evidence of a relevant neurological disorder other than MCI or mild dementia of the Alzheimer's type at screening, including but not limited to Parkinson's disease, Lewy body disease, frontotemporal dementia of any type, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, HIV (human immunodeficiency virus), learning disability, intellectual disability, hypoxic cerebral damage, or significant head trauma with loss of consciousness that led to persistent cognitive deficits
-Evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, including schizophrenia or other psychotic disorder, or bipolar disorder. A subject with a history of major depression who has not had an episode in the last 24 months before the day of screening and is considered in remission or whose depression is controlled with treatment can be included in the trial per investigator's judgement.
Source : Importé depuis le centre
Donnée non disponible
Cohortes
Donnée non disponible
Données à jour depuis :
11 février 2026
SITES ET CONTACTS
Centre principal
Centre intégré universitaire de santé et de services sociaux de l'Ouest-de-l’Île-de-Montréal
MONTRÉAL, QUÉBEC, CANADA
Recrutement local
—
FERMÉ
Dernière modification :
11 février 2026
Données à jour depuis :
11 fév.
Origine des données :
Nagano
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles
Identifiant
IUSMD-21-70 EVOKE
Titre
Essai clinique randomisé en double aveugle contrôlé par placebo étudiant l'effet et la sécurité de la semaglutide orale chez des sujets atteints de la maladie d'alzheimer précoce
Source : traduction non-officielle opérée par intelligence artificielle
voir le texte original
A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer’s disease
-Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
-MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria.
-CDR (Clinical Dementia Rating) global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home & hobbies, community affairs) Or CDR global score of 1.0
-RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index score of below or equal to 85
-MMSE (Mini-Mental State Examination) greater than or equal to 22
-Amyloid positivity established with either amyloid PET (positron emission tomography), CSF (cerebrospinal fluid) Aβ1-42 or CSF Aβ1-42/Aβ1-40 .
-If receiving an approved Alzheimer's disease treatment (such as acetylcholinesterase inhibitors, memantine or aducanumab) the dose must have been stable for at least 3 months prior to screening and should not be changed during the trial unless medically necessary.
Source : Importé depuis le centre
Critères d'exclusion
-Brain MRI (or CT) scan suggestive of clinically significant structural CNS disease confirmed by central read (e.g. cerebral large-vessel disease [large vessel (cortical) infarcts greater than 10 mm in diameter], prior macro-haemorrhage [greater than 1 cm^3], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus).
-Brain MRI (magnetic resonance imaging) (or CT) scan suggestive of significant small vessel pathology confirmed by central read and defined as greater than1 lacunar infarct and/or ARWMC (age-related white matter changes) greater than 2, (WM (white matter) greater than 20 mm) in the deep white matter and periventricular regions.
-Brain MRI (or CT) scan suggestive of strategic infarcts defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed by central read.
-Evidence of a relevant neurological disorder other than MCI or mild dementia of the Alzheimer's type at screening, including but not limited to Parkinson's disease, Lewy body disease, frontotemporal dementia of any type, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, HIV (human immunodeficiency virus), learning disability, intellectual disability, hypoxic cerebral damage, or significant head trauma with loss of consciousness that led to persistent cognitive deficits
-Evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, including schizophrenia or other psychotic disorder, or bipolar disorder. A subject with a history of major depression who has not had an episode in the last 24 months before the day of screening and is considered in remission or whose depression is controlled with treatment can be included in the trial per investigator's judgement.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Donnée non disponible
Cohortes
Donnée non disponible
Données à jour depuis :
11 février 2026
Description de l'étude
Description de l'étude
Résumé de l'étude
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.
Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.
The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.
Participants must have a study partner, who is willing to take part in the study.
Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.
A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
1
centres
CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DE L'OUEST-DE-L’ÎLE-DE-MONTRÉAL
***
Montréal
QUÉBEC, CANADA
Recrutement local
État du recrutement:
FERMÉ
cliquez ici pour plus d'informations pour ce centre
Cohortes
Centre intégré universitaire de santé et de services sociaux de l'Ouest-de-l’Île-de-Montréal
Donnée non disponible
Données à jour depuis :
11 février 2026
Source d'information
Dernière modification :
11 février 2026
Données à jour depuis :
11 fév.
Origine des données :
Nagano
