A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer*s disease (EVOKE)
- Conditions
- AlzheimerDementia10012272
- Registration Number
- NL-OMON51236
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 22
-Male or female, aged 55-85 years (both inclusive) at the time of signing
informed consent.
-MCI or mild dementia of the Alzheimer's type according to the National
Institute of Aging-Alzheimer's Association (NIA-AA) 2018 criteria.
-Clinical Dementia Rating (CDR) 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
-Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
delayed memory index score of less than or equal to 85
-Mini-Mental State Examination (MMSE) greater than or equal to 22.
-Amyloid positivity established with either amyloid positron emission
tomography (PET) or cerebrospinal fluid (CSF) Aβ1-42.
-If receiving an approved Alzheimer's disease treatment (such as
acetylcholinesterase inhibitors or memantine) 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
-Brain magnetic resonance imaging (MRI) (or computerised tomography (CT)) scan
suggestive of clinically significant structural central nervous system (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 (or CT) scan suggestive of significant small vessel pathology
confirmed by central read and defined as greater than 1 lacunar infarct and/or
age-related white matter changes (ARWMC) greater than 2, (white matter (WM)
greater than 20 mm).
-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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score From<br /><br>baseline (week 0) to week 104</p><br>
- Secondary Outcome Measures
Name Time Method