A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease

Last updated: January 2, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Neurologic Disorders

Treatment

Semaglutide

Placebo

Clinical Study ID

NCT05891496
NN6535-7519
2023-506825-13
2022-003384-24
U1111-1283-8743
  • Ages 55-75
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, aged 55-75 years (both inclusive) at the time of signing theinformed consent

  • Mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type accordingto 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 emissiontomography (PET) or historical cerebrospinal fluid (CSF) Aβ1-42 or historical CSFAβ1-42/Aβ1-40 (historical data within the last 5 years) or blood sample for amyloidbiomarker (Aβ42/Aβ40 ratio and p-tau217/np-tau217 ratio) at screening (visit 1)

  • Treated with acetylcholinesterase inhibitors (approved for the treatment ofAlzheimer's disease) and on stable dose for greater than 90 days before screening (visit 1)

Exclusion

Exclusion Criteria:

  • Brain magnetic resonance imaging (MRI) scan suggestive of clinically significantstructural central nervous system (CNS) disease confirmed by local read (examplecerebral large-vessel disease [large vessel (cortical) infarcts greater than 10millimeter (mm) in diameter], prior macro-haemorrhage [greater than 1centimeter cube (cm^3)], cerebral vascular malformations, cortical hemosiderosis, intracranialaneurism(s), intracranial tumours, changes suggestive of normal pressurehydrocephalus)

  • Brain MRI scan suggestive of significant small vessel pathology confirmed by localread and defined as greater than 1 lacunar infarct and/or white matterhyperintensity (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): Anyother medical condition that would require use of systemic corticosteroids orimmunosuppressants 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 thelast 12 months prior to screening (visit 1) or anticipated use of such drugs duringstudy intervention period 1 (i.e., during the first 12 weeks of treatment untilvisit 5), such as corticosteroids for systemic use, immunostimulants andimmunosuppressants

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
June 20, 2023
Estimated Completion Date:
September 11, 2025

Connect with a study center

  • Novo Nordisk Investigational Site

    Ottawa, Ontario K1Z 1G3
    Canada

    Active - Recruiting

  • Ottawa Memory Clinic

    Ottawa, Ontario K1Z 1G3
    Canada

    Site Not Available

  • Memory Program

    Toronto, Ontario M3B2S7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Toronto, Ontario M3B2S7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    København Ø, 2100
    Denmark

    Site Not Available

  • Rigshospitalet - afsnit 8015

    København Ø, 2100
    Denmark

    Site Not Available

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Brescia, 25123
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser

    Perugia, 06132
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Perugia, 06132
    Italy

    Site Not Available

  • Fondazione Santa Lucia IRCCS

    Roma, 00179
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Roma, 00179
    Italy

    Site Not Available

  • Karolinska Universitetssjukhuset, Huddinge

    Stockholm, 141 86
    Sweden

    Site Not Available

  • Novo Nordisk Investigational Site

    Stockholm, 141 86
    Sweden

    Active - Recruiting

  • Centre de la Mémoire

    Genève, 1205
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Genève, 1205
    Switzerland

    Active - Recruiting

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.