A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)
- Conditions
- Mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer’s typeMedDRA version: 20.0Level: LLTClassification code: 10001896Term: Alzheimer's disease Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-506918-45-00
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1953
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 NIA-AA 2018 criteria, 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, RBANS delayed memory index score of below or equal to 85, MMSE greater than or equal to 22, Amyloid positivity established with either amyloid PET or CSF A beta 1-42 or CSF A beta 1-42/A beta 1-40, 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
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 more than 10 mm in diameter], prior macro-haemorrhage [more than 1 cm3], 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 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, 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 who´s depression is controlled with treatment can be included in the trial per investigator’s judgement
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with MCI or mild dementia, both of the Alzheimer’s type;Secondary Objective: To compare the effects of oral semaglutide versus placebo in subjects with MCI or mild dementia, both of the Alzheimer’s type, on progression to dementia among subjects with MCI at baseline, To compare the effects of oral semaglutide versus placebo in subjects with MCI or mild dementia, both of the Alzheimer’s type, on neuropsychiatric symptoms, To compare the effects of oral semaglutide versus placebo in subjects with MCI or mild dementia, both of the Alzheimer’s type, on safety and tolerability, To compare the effects of oral semaglutide versus placebo in subjects with MCI or mild dementia, both of the Alzheimer’s type, on quality of life;Primary end point(s): Change in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) score. From baseline (week 0) to week 104. Score on scale (0 to 18)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Change in the Alzheimer’s Disease Cooperative Study Activities of Daily Living Scale for MCI (ADCS-ADL-MCI) score. From baseline (week 0) to week 104. Score on scale (0 to 53);Secondary end point(s):Time to progression to dementia (CDR global greater than or equal to 1.0) among subjects with MCI (CDR global equal to 0.5) at baseline. From baseline (week 0) to week 104. Week(s)