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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04777409
Registration number
NCT04777409
Ethics application status
Date submitted
26/02/2021
Date registered
2/03/2021
Date last updated
6/06/2024
Titles & IDs
Public title
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)
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Scientific title
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)
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Secondary ID [1]
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U1111-1259-2920
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Secondary ID [2]
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NN6535-4725
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Early Alzheimer´s Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Semaglutide
Treatment: Drugs - Placebo (semaglutide)
Experimental: Oral semaglutide 14 mg - Participants are given oral semaglutide once daily
Placebo Comparator: Placebo (semaglutide) - Participants are given oral placebo once daily
Treatment: Drugs: Semaglutide
Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
Treatment: Drugs: Placebo (semaglutide)
Oral placebo (semaglutide) once-daily. The study will last for up to 173 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score
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Assessment method [1]
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Score on scale (0 to 18)
Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease:
Cognitive domains: memory, orientation, and judgement and problem solving
Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains.
The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment.
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Timepoint [1]
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From baseline (week 0) to week 104
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Secondary outcome [1]
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Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for MCI (ADCS-ADLMCI) score
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Assessment method [1]
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Score on scale (0 to 53). An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment.
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Timepoint [1]
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From baseline (week 0) to week 104
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Secondary outcome [2]
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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
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Assessment method [2]
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Week(s)
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Timepoint [2]
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From baseline (week 0) to week 104
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Secondary outcome [3]
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Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score
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Assessment method [3]
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Score on scale (0 to 85) Measures the severity of cognitive impairment in various domains including memory, language, orientation, praxis and executive function. The total scores on the scale range from 0 to 85 with higher scores representing greater impairment.
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Timepoint [3]
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From baseline (week 0) to week 104
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Secondary outcome [4]
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Change in the Montreal Cognitive Assessment (MoCA) score
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Assessment method [4]
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Score on scale (0 to 30) The assessment includes 8 domains of cognitive function with total scores ranging from 0 to 30 and lower scores indicating greater impairment.
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Timepoint [4]
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From baseline (week 0) to week 104
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Secondary outcome [5]
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Change in the Alzheimer's Disease Composite Score (ADCOMS)
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Assessment method [5]
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Score on scale (0 to 1.97) The ADCOMS is a composite clinical outcome comprising 4 items from the ADAS-Cog-13, 2 items from the MMSE and all 6 items from the CDR-SB.32 The total scores on the scale range from 0 to 1.97 with higher scores indicating greater impairment.
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Timepoint [5]
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From baseline (week 0) to week 104
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Secondary outcome [6]
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Change in the Mini-Mental State Examination (MMSE) score
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Assessment method [6]
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Score on scale (0 to 30) The MMSE measures orientation, attention, memory, language and visuo-spatial function. The total scores on the scale range from 0 to 30 with lower scores indicating greater impairment.
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Timepoint [6]
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From baseline (week 0) to week 104
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Secondary outcome [7]
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Change in the 10-item Neuropsychiatric Inventory (NPI) score
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Assessment method [7]
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104 Score on scale (0 to 120) The 10-item scale assesses symptoms including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability and aberrant motor activity. For each domain the frequency (4-point scale) and severity (3-point scale) of symptoms is reported. The score for each domain is calculated by multiplying the frequency and severity score. The total 10-item NPI score is 0 to 120 with higher scores indicating a greater symptomatology.
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Timepoint [7]
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From baseline (week 0) to week 104
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Secondary outcome [8]
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Time to progression in disease stage based on global CDR score
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Assessment method [8]
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Week(s)
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Timepoint [8]
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From baseline (week 0) to week 104
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Secondary outcome [9]
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Number of treatment emergent adverse events (TEAEs)
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Assessment method [9]
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Number of events
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Timepoint [9]
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From baseline (week 0) to week 104
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Secondary outcome [10]
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Change in high sensitivity C-reactive protein level
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Assessment method [10]
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Ratio
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Timepoint [10]
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From baseline (week 0) to week 104
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Secondary outcome [11]
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Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and allcause death
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Assessment method [11]
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Week(s)
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Timepoint [11]
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Secondary outcome [12]
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Time to first occurrence of stroke
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Assessment method [12]
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Weeks
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Timepoint [12]
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From baseline (week 0) to week 104
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Secondary outcome [13]
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Change in the EQ-5D-5L proxy score
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Assessment method [13]
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Score The EQ-5D-5L descriptive system comprises mobility, self-care, usual activities, pain/discomfort and anxiety/depression with five response levels each (no problems, slight problems, moderate problems, severe problems, unable to /extreme problems). The EQ-5D-5L proxy version 1 (the study partner is asked to rate how he/she [the proxy] would rate the subject´s health) will be used in this trial.
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Timepoint [13]
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From baseline (week 0) to week 104
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Secondary outcome [14]
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Extension phase: Change in the CDR-SB score
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Assessment method [14]
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Score on scale (0 to 18)
Measures the impact of cognitive decline on daily function using the following six domains commonly affected in Alzheimer's disease:
Cognitive domains: memory, orientation, and judgement and problem solving
Function domains: community affairs, home and hobbies, and personal care Based on clinical information obtained from the subject and informant, an individual box score ranging from 0 to 3 is determined that represents "none" to "severe" impairment for each of the six domains.
The CDR-Sum of Boxes (CDR-SB) score will be derived by adding the individual scores of the six domains at a given time point. The total CDR-SB score ranges from 0 to 18 with higher scores representing greater impairment.
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Timepoint [14]
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From baseline (week 0) to week 156
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Secondary outcome [15]
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Extension phase: Change in the ADCS-ADL-MCI score
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Assessment method [15]
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Score on scale (0 to 53) An interview-based assessment of information provided by the study partner (informant). The total scores based on 18 items on the scale range from 0 to 53 with lower scores representing greater impairment.
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Timepoint [15]
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From baseline (week 0) to week 156
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Secondary outcome [16]
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Extension phase: 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
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Assessment method [16]
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Week(s)
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Timepoint [16]
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From baseline (week 0) to week 156
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Eligibility
Key inclusion criteria
- Male or female, aged 55-85 years (both inclusive) at the time of signing informed
consent.
- MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to
the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria.
- CDR (Clinical Dementia Rating) 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 (Repeatable Battery for the Assessment of Neuropsychological Status) delayed
memory index score of below or equal to 85
- MMSE (Mini-Mental State Examination) greater than or equal to 22
- Amyloid positivity established with either amyloid PET (positron emission tomography),
CSF (cerebrospinal fluid) 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.
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Minimum age
55
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Brain MRI (or CT) scan suggestive of clinically significant structural CNS (central
nervous system) disease confirmed by central read (e.g. cerebral large-vessel disease
[large vessel (cortical) infarcts greater than10 mm in diameter], prior
macro-haemorrhage [greater than1 cm^3], cerebral vascular malformations, cortical
hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of
normal pressure hydrocephalus).
- Brain MRI (magnetic resonance imaging) (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 (human immunodeficiency virus), 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/10/2026
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Actual
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Sample size
Target
1840
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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St Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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Southern Neurology - Kogarah
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Recruitment hospital [3]
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KaRa Institute of Neurological Disease Pty Ltd - Macquarie Park
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Recruitment hospital [4]
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Hunter New England Local Health District - Neuropsychiatry - Waratah
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Recruitment hospital [5]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [6]
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Medical and Cognitive Research Unit - Austin Health - Ivanhoe
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Recruitment hospital [7]
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HammondCare - Malvern
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Recruitment hospital [8]
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Alzheimer's Research Australia - Nedlands
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Recruitment hospital [9]
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Australian Alzheimer's Research Foundation Incorporated - Nedlands
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2113 - Macquarie Park
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Recruitment postcode(s) [4]
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2298 - Waratah
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Recruitment postcode(s) [5]
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4032 - Chermside
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Recruitment postcode(s) [6]
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3079 - Ivanhoe
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Recruitment postcode(s) [7]
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3144 - Malvern
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Colorado
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Turku
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France
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Bordeaux
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France
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Bron
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France
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Dijon
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France
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Marseille
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France
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Nice
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France
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Paris
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France
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Reims cedex
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France
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Saint Herblain
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France
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Strasbourg
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France
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Toulouse
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France
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Villeurbanne
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Germany
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Köln
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Germany
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Münster
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Athens
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Greece
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Chaidari, Athens
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Thessaloniki
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Budapest
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Debrecen
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Gyor
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Hungary
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Hungary
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Kaposvár
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Pécs
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Hungary
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Dublin
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Haifa
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Tel Hashomer, Ramat Gan
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Italy
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Ancona
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Italy
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Brescia
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Italy
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Chieti
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Italy
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Firenze
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Italy
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Milano
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Italy
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Monza
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Italy
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Torino
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Anan, Tokushima
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Bunkyo-ku, Tokyo
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Hachioji-shi, Tokyo
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Hirakata-Shi,Osaka
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Kanagawa
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Kawasaki-shi, Kanagawa
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Tokyo
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Toyonaka-shi, Osaka
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Wako-shi, Saitama
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Korea, Republic of
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Busan
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Incheon
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Seoul
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Breda
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Lublin
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Scinawa
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Sopot
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Portugal
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Braga
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Portugal
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Portugal
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Portugal
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Lisboa
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Portugal
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Loures
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Portugal
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Matosinhos
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Portugal
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Porto
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Portugal
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Romania
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Constanta
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Romania
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Sibiu
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Russian Federation
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Ekaterinburg
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Omsk
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Russian Federation
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Russian Federation
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Russian Federation
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Tomsk
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Russian Federation
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Ufa
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Serbia
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Belgrade
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Serbia
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Kovin
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Serbia
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Novi Sad
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Bratislava
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Kosice
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Ljubljana
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Maribor
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Gauteng
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Barcelona
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Spain
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Spain
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Valencia
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Malmö
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Umeå
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Lausanne
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St. Gallen
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Taiwan
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Kharkiv
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Odesa
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United Kingdom
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Aberdeen
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Bath
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Crowborough
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United Kingdom
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Motherwell
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Oxford
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United Kingdom
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Southampton
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United Kingdom
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Swindon
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is done to find out whether the medicine, semaglutide, has a positive effect on
early Alzheimer's disease.
Participants will either get semaglutide or placebo (a "dummy" medicine which does not
contain any study medicine) - which treatment participants get is decided by an equal chance.
The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have
17 clinic visits and 1 phone call with the study doctor. The study includes various tests and
scans. At 10 of the clinic visits participants will have blood samples taken.
Participants must have a study partner, who is willing to take part in the study.
Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study
period.
A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study
will be performed on a selection of sites based on their experience with CSF sampling and
willingness to participate in this sub-study. The endpoints related to this sub-study are
exploratory only.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04777409
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Transparency (dept. 2834)
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Address
0
0
Novo Nordisk A/S
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Country
0
0
Query!
Phone
0
0
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Fax
0
0
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Email
0
0
Query!
Contact person for public queries
Name
0
0
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Address
0
0
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Country
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0
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Phone
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0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04777409
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