Informations générales (source: ClinicalTrials.gov)
A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)
Interventional
Phase 3
Novo Nordisk A/S (Voir sur ClinicalTrials)
mai 2021
octobre 2026
02 décembre 2025
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.
Etablissements
| Etablissement | Contact | Statut | Actualisé | ||
|---|---|---|---|---|---|
| Etablissement non spécifié, référez vous à la page NCT pour plus d'information Origine et niveau de fiabilité des données | |||||
Critères
Tous
- 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 study unless
medically necessary.
Exclusion Criteria:
- Brain Magnetic resonance imaging (MRI) (or Computed Tomography (CT)) scan suggestive
of clinically significant structural CNS (central nervous system) disease confirmed
by central read (e.g. cerebral large-vessel disease [large vessel (cortical)
infarcts greater than (>) 10 milimeter (mm) in diameter], prior macro-haemorrhage
[greater than 1 cubic centimetre (cm^3)], cerebral vascular malformations, cortical
hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of
normal pressure hydrocephalus).
- 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 mild cognitive impairment
(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, human
immunodeficiency virus (HIV), 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 participant 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 study per investigator's judgement.