Semaglutide

A clinical study investigating the effect of semaglutide on the immune system and other biological processes in people with early Alzheimer's disease

Conditions

Prodromal/Mild Cognitive Impairment due to Alzheimer’s disease

Mild Alzheimer's dementia

Sponsor

Novo Nordisk A/S

Clinical Trial

Phase III

Status

Ongoing studies but not recruiting

Drug

Semaglutide

Countries

Denmark, Sweden, Switzerland

Information about the drug that will be tested in the study

Administration

The study partner will use a pen injector to give the participant an injection into the skin of their stomach, thigh, or upper arm once every week.

Is the drug already on the market for another medical condition?

Yes - semaglutide is a medicine that doctors can prescribe in some countries for the treatment of type 2 diabetes and excess body weight

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

A subcutaneous injection of semaglutide
A subcutaneous injection of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor their doctor will know if the person is receiving the investigational drug (semaglutide) or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to look at the effect of semaglutide on the immune system and other biological processes in people with early Alzheimer's disease to gain further understanding of how semaglutide works and may benefit people with early Alzheimer's disease.

How long will the treatment last?

About 77 weeks

In the first 12 weeks of treatment, participants will either get semaglutide or placebo. In the following 52 weeks of treatment, all participants taking part in the study will get semaglutide.

What your involvement will entail?

Prior to study initiation, participants will have to undergo an MRI brain scan.

At the start if the study, participants will be asked to complete a number of tests that will assess memory, orientation, judgment and problem solving, personal care and community affairs using a test called CDR-GS.

During the study, participants will be asked to undergo blood sampling and CSF examination (spinal tap).

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

Be between 55 and 75 years old
Have a diagnosis of mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type
Have a score of 0.5 or 1 in the Clinical Dementia Rating-Global Score (CDR-GS). This would suggest that the person has an impairment at a mild stage
Have evidence of abnormal accumulation of amyloid in their brain (established by PET scan or CSF lumbar puncture or blood sample)
Be treated with acetylcholinesterase inhibitors (approved for the treatment of Alzheimer's disease) and on stable dose for greater than 90 days before screening
Must have a study partner, who is willing to take part in the study and willing to participate in study procedures throughout the study duration (e.g. injecting participant with weekly injections).

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced (main exclusion criteria):

Brain MRI scan results suggesting clinically significant structural central nervous system (CNS) diseases (e.g. cerebral large-vessel disease, macro-haemorrhage, cerebral vascular malformations, small vessel pathology)
History or evidence of autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, lupus, glomerulonephritis, psoriasis
Received a vaccine product 4 weeks prior to screening
Use of any systemic immunomodulating drugs in the last 12 months (e.g. corticosteroids for systemic use, immunostimulants and immunosuppressants).

Note that this list is not exhaustive but it rather focuses on the most common conditions and diseases excluding people from the study.