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A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)
EU CTIS ID: 2023-506918-45-00
What this study is testing
To confirm the superiority of oral semaglutide once daily versus placebo when added to standard of care with respect to the change in cognition and function as measured by the Clinical Dementia Rating – Sum of Boxes (CDR-SB) score from baseline to week 104 in patients with MCI or mild dementia, both of the Alzheimer’s type.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
- Brazil
- China
- Canada
- Taiwan
- South Africa
- Serbia
- United States
- Korea, Democratic People's Republic of
- United Kingdom
- Switzerland
- Ukraine
- Israel
- Turkey
- Argentina
- Australia
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation; Brazil; China; Canada; Taiwan; South Africa and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.