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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04777409




Registration number
NCT04777409
Ethics application status
Date submitted
26/02/2021
Date registered
2/03/2021

Titles & IDs
Public title
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)
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)
Secondary ID [1] 0 0
U1111-1259-2920
Secondary ID [2] 0 0
NN6535-4725
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Alzheimer´s Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score
Timepoint [1] 0 0
From baseline (week 0) to week 104
Secondary outcome [1] 0 0
Change in the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale for MCI (ADCS-ADLMCI) score
Timepoint [1] 0 0
From baseline (week 0) to week 104
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
From baseline (week 0) to week 104
Secondary outcome [3] 0 0
Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score
Timepoint [3] 0 0
From baseline (week 0) to week 104
Secondary outcome [4] 0 0
Change in the Montreal Cognitive Assessment (MoCA) score
Timepoint [4] 0 0
From baseline (week 0) to week 104
Secondary outcome [5] 0 0
Change in the Alzheimer's Disease Composite Score (ADCOMS)
Timepoint [5] 0 0
From baseline (week 0) to week 104
Secondary outcome [6] 0 0
Change in the Mini-Mental State Examination (MMSE) score
Timepoint [6] 0 0
From baseline (week 0) to week 104
Secondary outcome [7] 0 0
Change in the 10-item Neuropsychiatric Inventory (NPI) score
Timepoint [7] 0 0
From baseline (week 0) to week 104
Secondary outcome [8] 0 0
Time to progression in disease stage based on global CDR score
Timepoint [8] 0 0
From baseline (week 0) to week 104
Secondary outcome [9] 0 0
Number of treatment emergent adverse events (TEAEs)
Timepoint [9] 0 0
From baseline (week 0) to week 104
Secondary outcome [10] 0 0
Change in high sensitivity C-reactive protein level
Timepoint [10] 0 0
From baseline (week 0) to week 104
Secondary outcome [11] 0 0
Time to first occurrence of major adverse cardiovascular event (MACE) comprising non-fatal myocardial infarction, non-fatal stroke and allcause death
Timepoint [11] 0 0
From baseline (week 0) to week 104
Secondary outcome [12] 0 0
Time to first occurrence of stroke
Timepoint [12] 0 0
From baseline (week 0) to week 104
Secondary outcome [13] 0 0
Change in the EQ-5D-5L proxy score
Timepoint [13] 0 0
From baseline (week 0) to week 104
Secondary outcome [14] 0 0
Extension phase: Change in the CDR-SB score
Timepoint [14] 0 0
From baseline (week 0) to week 156
Secondary outcome [15] 0 0
Extension phase: Change in the ADCS-ADL-MCI score
Timepoint [15] 0 0
From baseline (week 0) to week 156
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
From baseline (week 0) to week 156

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.
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/10/2026
Actual
Sample size
Target
1840
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Southern Neurology - Kogarah
Recruitment hospital [3] 0 0
KaRa Institute of Neurological Disease Pty Ltd - Macquarie Park
Recruitment hospital [4] 0 0
Hunter New England Local Health District - Neuropsychiatry - Waratah
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Medical and Cognitive Research Unit - Austin Health - Ivanhoe
Recruitment hospital [7] 0 0
HammondCare - Malvern
Recruitment hospital [8] 0 0
Alzheimer's Research Australia - Nedlands
Recruitment hospital [9] 0 0
Australian Alzheimer's Research Foundation Incorporated - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [7] 0 0
3144 - Malvern
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
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Tel Aviv
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Israel
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Tel Hashomer, Ramat Gan
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Ancona
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Roma
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Torino
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Anan, Tokushima
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Bunkyo-ku, Tokyo
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Japan
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Bunkyo-ku,Tokyo
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Chib-shi, Chiba
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Chofu-shi,Tokyo
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Fujioka-Shi, Gunma
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Hachioji-shi, Tokyo
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Hamamatsu-shi, Shizuoka
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Himeji-city, Hyogo
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Himeji-shi, Hyogo
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Hirakata-Shi,Osaka
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Hiroshima-shi, Hiroshima
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Hofu-shi, Yamaguchi
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Ina-shi, Nagano
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Kanagawa
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Kawasaki-shi , Kanagawa
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Kobe-shi, Hyogo
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Kodaira-shi, Tokyo
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Koriyama-shi, Fukushima
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Kurashiki-shi, Okayama
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Mitaka-shi,Tokyo
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Nerima-ku, Tokyo
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Sopot
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Guimarães
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Lisboa
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Loures
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Porto
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Romania
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Constanta
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Sibiu
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Ekaterinburg
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Rostov-on-Don
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Russian Federation
State/province [187] 0 0
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04777409