EUCTR2020-004864-25-FIActive, not recruitingPhase 1
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)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 1,840
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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), CSF Aß1-42 or CSF Aß1-42/Aß1-40.
- •- 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 276
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1564
Exclusion Criteria
- •- 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 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.
Investigators
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