Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1283-8743 | Other Identifier | World Health Organisation (WHO) | |
| 2022-003384-24 | EudraCT Number | ||
| 2023-506825-13 | Other Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Semagllutide will be administered once weekly subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Baseline (week 0), week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States | ||
| Brain Matters Research |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Participants with mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer's type were randomised in 1:1 ratio to receive subcutaneous (s.c.) injection of once weekly semaglutide or placebo matched to semaglutide. The final data for outcome measures 1,2 and 3 are reported with no further updates. Adverse events are presented for period 1 + period 2.
The trial was conducted at 7 sites in 5 countries (Canada, Denmark, Sweden, Switzerland and the United States).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Semaglutide | Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: 12 Weeks |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2024 | Oct 10, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matched to semaglutide will be administered once weekly subcutaneously. |
|
| From baseline (week 0) to week 12 |
| Number of TEAEs | From baseline (week 0) to week 64 |
| Weekly Average Semaglutide Concentration [Average Concentration (Cavg)] Based on Population Pharmacokinetics (PK) Analysis | From week 4 to week 64 |
| Delray Beach |
| Florida |
| 33445 |
| United States |
| Ottawa Memory Clinic | Ottawa | Ontario | K1Z 1G3 | Canada |
| Memory Program | Toronto | Ontario | M3B2S7 | Canada |
| Rigshospitalet - afsnit 8015 Hukommelsesklinikken | København Ø | 2100 | Denmark |
| Rigshospitalet - afsnit 8015 | København Ø | 2100 | Denmark |
| Azienda Ospedaliera Spedali Civili di Brescia | Brescia | 25123 | Italy |
| Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser | Perugia | 06132 | Italy |
| Fondazione Santa Lucia IRCCS | Roma | 00179 | Italy |
| Karolinska Universitetssjukhuset, Huddinge | Stockholm | 141 86 | Sweden |
| Centre de la Mémoire | Geneva | 1205 | Switzerland |
| Placebo |
Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks. |
| FG002 | Placebo to Semaglutide | Participants who initially received placebo was administered with semaglutide every 4 weeks in a dose escalation manner. |
| Full Analysis Set |
|
| Safety Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Period 2: 52 Weeks |
|
|
Full analysis set (FAS) included all randomised participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Semaglutide | Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached. |
| BG001 | Placebo | Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Full analysis set (FAS) comprised all randomised participants. Here, Overall 'Number of Participants Analysed' refers to the number of participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Differentially expressed genes | Baseline (week 0), week 12 |
|
|
| ||||||||||||||||||||||||||||
| Primary | 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. | FAS comprised all randomised participants. Here, Overall 'Number of Participants Analysed' refers to the number of participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Differentially expressed genes | Baseline (week 0), week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set (SAS) included all participants exposed to study intervention. | Posted | Number | Events | From baseline (week 0) to week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of TEAEs | Not Posted | Sep 2026 | From baseline (week 0) to week 64 | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Weekly Average Semaglutide Concentration [Average Concentration (Cavg)] Based on Population Pharmacokinetics (PK) Analysis | Not Posted | Sep 2026 | From week 4 to week 64 | Participants |
From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Semaglutide Period 1 | Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached. | 0 | 11 | 0 | 11 | 9 | 11 |
| EG001 | Placebo | Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks. | 0 | 12 | 0 | 12 | 5 | 12 |
| EG002 | Semaglutide Period 2 | Participants from semaglutide period 1 arm received once weekly s.c. injection of maintenance dose semaglutide and participants from placebo arm received s.c. administration of semaglutide in dose escalation manner until the maintenance dose was reached up to 64 weeks. | 1 | 22 | 1 | 22 | 15 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 28 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 28 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 28 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 28 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28 | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2024 | Oct 10, 2025 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|