Alzheimers DiseasePhase 3NCT05891496
A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease
A Phase 3 study testing Semaglutide in people with Alzheimers Disease, run by Novo Nordisk A/S at 12 sites in 6 countries.
Trial summary
The study is being conducted to understand how the medicine, semaglutide, affects the immune system and other biological processes in people with Alzheimer's disease. Semaglutide is a medicine that doctors can prescribe in some countries for the treatment of type 2 diabetes and excess body weight. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Alzheimers Disease
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 20 Jun 2023to 8 Sep 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 55-75 years (both inclusive) at the time of signing the informed consent
- Mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type according to the National Institute on Aging- Alzheimer's Association (NIA-AA) 2018 criteria
- Clinical dementia rating (CDR) global score of 0.5 or 1 at screening (visit 1)
- Amyloid positivity established with either historical amyloid positron emission tomography (PET) or historical cerebrospinal fluid (CSF) Aβ1-42 or historical CSF Aβ1-42/Aβ1-40 (historical data within the last 5 years) or blood sample for amyloid biomarker (Aβ42/Aβ40 ratio and p-tau217/np-tau217 ratio) at screening (visit 1)
- Treated with acetylcholinesterase inhibitors (approved for the treatment of Alzheimer's disease) and on stable dose for greater than 90 days before screening (visit 1)
Who cannot join
- Brain magnetic resonance imaging (MRI) scan suggestive of clinically significant structural central nervous system (CNS) disease confirmed by local read (example cerebral large-vessel disease [large vessel (cortical) infarcts greater than 10 millimeter (mm) in diameter], prior macro-haemorrhage [greater than 1centimeter cube (cm^3)], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus)
- Brain MRI scan suggestive of significant small vessel pathology confirmed by local read and defined as greater than 1 lacunar infarct and/or white matter hyperintensity (WMH) Fazekas13 scale greater than 2, (white matter [WM] greater than 20 mm) in the deep white matter and periventricular regions
- History or evidence of autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, lupus, glomerulonephritis, psoriasis (but not limited to): Any other medical condition that would require use of systemic corticosteroids or immunosuppressants or immunostimulants in the 12 months prior to screening (visit 1)
- Received a vaccine product (including booster) 4 weeks prior to screening (visit 1) or expected to receive a vaccine product (including booster) before visit 5
- Use of any systemic immunomodulating drugs (small molecules and/or biologics) in the last 12 months prior to screening (visit 1) or anticipated use of such drugs during study intervention period 1 (i.e., during the first 12 weeks of treatment until visit 5), such as corticosteroids for systemic use, immunostimulants and immunosuppressants
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Italy4 sites
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, 06132
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser
Perugia, 06132
Fondazione Santa Lucia IRCCS
Roma, 00179
United States2 sites
Brain Matters Research
Delray Beach, Florida, 33445
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Canada2 sites
Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3
Memory Program
Toronto, Ontario, M3B2S7
Denmark2 sites
Rigshospitalet - afsnit 8015 Hukommelsesklinikken
København Ø, 2100
Rigshospitalet - afsnit 8015
København Ø, 2100
About this study
Official title: A Randomised Double-blind Placebo-controlled Clinical Study Investigating the Effects of Semaglutide s.c. Once-weekly Versus Placebo on Central and Peripheral Inflammation in Participants With Alzheimer's Disease
The study is being conducted to understand how the medicine, semaglutide, affects the immune system and other biological processes in people with Alzheimer's disease. Semaglutide is a medicine that doctors can prescribe in some countries for the treatment of type 2 diabetes and excess body weight. This study will help us understand whether semaglutide can also be used for the treatment of Alzheimer's disease. The study will last for about 77 weeks. In the first 12 weeks of treatment, participants will either get semaglutide (active medicine) or placebo (inactive dummy medicine). Which treatment participants get is decided by chance. In the following 52 weeks of treatment, all participants taking part in the study will get semaglutide. Participants must have a study partner, who is willing to take part in the study. Participants will get study medicine in a pen injector. The study partner will need to inject the study medicine into the skin of participant's stomach, thigh or upper arm once every week.
- Conditions
- Alzheimers Disease
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semagllutide will be administered once weekly subcutaneously.
PlaceboDrug
Placebo matched to semaglutide will be administered once weekly subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Study intervention period 1 | Experimental | Participants will receive either semaglutide or placebo matched to semaglutide once-weekly subcutaneous (s.c.) injections for 12 weeks as an add on therapy to standard of care. Participants initially received 0.25 milligram (mg) once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (1.0 mg) was reached: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12). Receives: Drug: Semaglutide; Drug: Placebo |
| Study intervention period 2 | Placebo comparator | All participants will receive 1.0 mg semaglutide s.c. injections once weekly for 52 weeks during study intervention period 2 as an add-on therapy to standard of care. Participants randomised to semaglutide s.c. 1.0 mg during study intervention period 1 remained on 1.0 mg target maintenance dose for 52 weeks from weeks 12-64. Participants initially randomised to placebo during study intervention period 1 will receive semaglutide s.c. in dose escalation fashion for 8 weeks (0.25 mg from weeks 12-16 and 0.5 mg from weeks 16-20) followed by a maintenance period from weeks 20-64 at dose 1.0 mg. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF])
Change in gene expression assessed by scRNAseq (cells in CSF) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes (DEG).
Measured: Baseline (week 0), week 12
Change in Gene Expression Assessed by scRNAseq (Cells in Blood)
Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes.
Measured: Baseline (week 0), week 12
Secondary outcomes (3)
Number of Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment period.
Measured: From baseline (week 0) to week 12
Number of TEAEs
Measured: From baseline (week 0) to week 64
Weekly Average Semaglutide Concentration [Average Concentration (Cavg)] Based on Population Pharmacokinetics (PK) Analysis
Measured: From week 4 to week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start20 Jun 2023
- Primary completion19 Aug 2024
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimers DiseaseStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891496
- Sponsor's protocol ID
- NN6535-7519
- Other IDs
- U1111-1283-8743, 2022-003384-24, 2023-506825-13, 2023
- Status last verified
- Aug 2026
- First submitted
- 29 May 2023
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Placebo-controlled Clinical Study Investigating the Effects of Semaglutide s.c. Once-weekly Versus Placebo on Central and Peripheral Inflammation in Participants With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05891496
- Acronym / sponsor ID
- NN6535-7519
- Conditions
- Alzheimers Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Posted 24 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to understand how the medicine, semaglutide, affects the immune system and other biological processes in people with Alzheimer's disease. Semaglutide is a medicine that doctors can prescribe in some countries for the treatment of type 2 diabetes and excess body weight. This study will help us understand whether semaglutide can also be used for the treatment of Alzheimer's disease. The study will last for about 77 weeks. In the first 12 weeks of treatment, participants will either get semaglutide (active medicine) or placebo (inactive dummy medicine). Which treatment participants get is decided by chance. In the following 52 weeks of treatment, all participants taking part in the study will get semaglutide. Participants must have a study partner, who is willing to take part in the study. Participants will get study medicine in a pen injector. The study partner will need to inject the study medicine into the skin of participant's stomach, thigh or upper arm once every week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study intervention period 1 | Experimental | Drug: Semaglutide, Drug: PlaceboParticipants will receive either semaglutide or placebo matched to semaglutide once-weekly subcutaneous (s.c.) injections for 12 weeks as an add on therapy to standard of care. Participants initially received 0.25 milligram (mg) once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (1.0 mg) was reached: 0.25 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12). |
| Study intervention period 2 | Placebo comparator | Drug: SemaglutideAll participants will receive 1.0 mg semaglutide s.c. injections once weekly for 52 weeks during study intervention period 2 as an add-on therapy to standard of care. Participants randomised to semaglutide s.c. 1.0 mg during study intervention period 1 remained on 1.0 mg target maintenance dose for 52 weeks from weeks 12-64. Participants initially randomised to placebo during study intervention period 1 will receive semaglutide s.c. in dose escalation fashion for 8 weeks (0.25 mg from weeks 12-16 and 0.5 mg from weeks 16-20) followed by a maintenance period from weeks 20-64 at dose 1.0 mg. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 55-75 years (both inclusive) at the time of signing the informed consent
- Mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type according to the National Institute on Aging- Alzheimer's Association (NIA-AA) 2018 criteria
- Clinical dementia rating (CDR) global score of 0.5 or 1 at screening (visit 1)
- Amyloid positivity established with either historical amyloid positron emission tomography (PET) or historical cerebrospinal fluid (CSF) Aβ1-42 or historical CSF Aβ1-42/Aβ1-40 (historical data within the last 5 years) or blood sample for amyloid biomarker (Aβ42/Aβ40 ratio and p-tau217/np-tau217 ratio) at screening (visit 1)
- Treated with acetylcholinesterase inhibitors (approved for the treatment of Alzheimer's disease) and on stable dose for greater than 90 days before screening (visit 1)
Key exclusion criteria (5 listed)
- Brain magnetic resonance imaging (MRI) scan suggestive of clinically significant structural central nervous system (CNS) disease confirmed by local read (example cerebral large-vessel disease [large vessel (cortical) infarcts greater than 10 millimeter (mm) in diameter], prior macro-haemorrhage [greater than 1centimeter cube (cm^3)], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus)
- Brain MRI scan suggestive of significant small vessel pathology confirmed by local read and defined as greater than 1 lacunar infarct and/or white matter hyperintensity (WMH) Fazekas13 scale greater than 2, (white matter [WM] greater than 20 mm) in the deep white matter and periventricular regions
- History or evidence of autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, lupus, glomerulonephritis, psoriasis (but not limited to): Any other medical condition that would require use of systemic corticosteroids or immunosuppressants or immunostimulants in the 12 months prior to screening (visit 1)
- Received a vaccine product (including booster) 4 weeks prior to screening (visit 1) or expected to receive a vaccine product (including booster) before visit 5
- Use of any systemic immunomodulating drugs (small molecules and/or biologics) in the last 12 months prior to screening (visit 1) or anticipated use of such drugs during study intervention period 1 (i.e., during the first 12 weeks of treatment until visit 5), such as corticosteroids for systemic use, immunostimulants and immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemagllutide will be administered once weekly subcutaneously. | Drug | Study intervention period 1, Study intervention period 2 |
| PlaceboPlacebo matched to semaglutide will be administered once weekly subcutaneously. | Drug | Study intervention period 1 |
Primary outcome
Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF])
Time frame: Baseline (week 0), week 12
Change in gene expression assessed by scRNAseq (cells in CSF) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes (DEG).
Change in Gene Expression Assessed by scRNAseq (Cells in Blood)
Time frame: Baseline (week 0), week 12
Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes.
3 secondary outcomes
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline (week 0) to week 12
Number of TEAEs
Time frame: From baseline (week 0) to week 64
Weekly Average Semaglutide Concentration [Average Concentration (Cavg)] Based on Population Pharmacokinetics (PK) Analysis
Time frame: From week 4 to week 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Alzheimers Disease, run by Novo Nordisk A/S at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, United States, Canada, Denmark, Sweden and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF]) (time frame: Baseline (week 0), week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.