A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)
- Conditions
- Early Alzheimer´s Disease
- Registration Number
- NCT04777409
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 1840
Inclusion Criteria:<br><br> - Male or female, aged 55-85 years (both inclusive) at the time of signing informed<br> consent.<br><br> - MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according<br> to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria.<br><br> - CDR (Clinical Dementia Rating) global score of 0.5 and CDR of 0.5 or more in at<br> least one of the three instrumental activities of daily living categories (personal<br> care, home & hobbies, community affairs) Or CDR global score of 1.0<br><br> - RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed<br> memory index score of below or equal to 85<br><br> - MMSE (Mini-Mental State Examination) greater than or equal to 22<br><br> - Amyloid positivity established with either amyloid PET (positron emission<br> tomography), CSF (cerebrospinal fluid) Aß1-42 or CSF Aß1-42/Aß1-40.<br><br> - If receiving an approved Alzheimer's disease treatment (such as acetylcholinesterase<br> inhibitors, memantine or aducanumab) the dose must have been stable for at least 3<br> months prior to screening and should not be changed during the trial unless<br> medically necessary.<br><br>Exclusion Criteria:<br><br> - Brain MRI (or CT) scan suggestive of clinically significant structural CNS (central<br> nervous system) disease confirmed by central read (e.g. cerebral large-vessel<br> disease [large vessel (cortical) infarcts greater than10 mm in diameter], prior<br> macro-haemorrhage [greater than1 cm^3], cerebral vascular malformations, cortical<br> hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of<br> normal pressure hydrocephalus).<br><br> - Brain MRI (magnetic resonance imaging) (or CT) scan suggestive of strategic infarcts<br> defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic<br> infarcts confirmed by central read.<br><br> - Evidence of a relevant neurological disorder other than MCI or mild dementia of the<br> Alzheimer's type at screening, including but not limited to Parkinson's disease,<br> Lewy body disease, frontotemporal dementia of any type, Huntington's disease,<br> amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus,<br> progressive supranuclear palsy, neurosyphilis, HIV (human immunodeficiency virus),<br> learning disability, intellectual disability, hypoxic cerebral damage, or<br> significant head trauma with loss of consciousness that led to persistent cognitive<br> deficits.<br><br> - Evidence of a clinically relevant or unstable psychiatric disorder, based on<br> Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, including<br> schizophrenia or other psychotic disorder, or bipolar disorder. A subject with a<br> history of major depression who has not had an episode in the last 24 months before<br> the day of screening and is considered in remission or whose depression is<br> controlled with treatment can be included in the trial per investigator's judgement.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score
- Secondary Outcome Measures
Name Time Method