What side effects are associated with this type of intervention?

Common side effects of GLP-1 receptor agonists, such as semaglutide, include gastrointestinal symptoms like nausea, vomiting, and diarrhea. There are also concerns about the risk of pancreatitis and potential thyroid C-cell tumors, although the latter is more evident in animal studies than in humans. For Alzheimer's treatments broadly, side effects can vary depending on the specific medication but often include gastrointestinal issues, dizziness, headaches, and potential worsening of cognitive function in some cases.

What prior FDA approvals exist?

The FDA has approved aducanumab for the treatment of Alzheimer's Disease, primarily for patients with mild cognitive impairment or mild dementia due to Alzheimer's. Aducanumab targets amyloid beta plaques, a hallmark of Alzheimer's pathology. However, its approval was controversial due to uncertainties about its clinical benefits. There is no specific mention of GLP-1 receptor agonists like semaglutide being approved for Alzheimer's Disease in the provided context. Current research, including the study on semaglutide, aims to explore new potential treatments for Alzheimer's by investigating their effects on the immune system and other biological processes.

What other types of research exist?

Promising alternatives to Semaglutide for Alzheimer's Disease patients include Liraglutide and Lixisenatide. Both have shown neuroprotective effects, improved cognitive function, and reduced amyloid-beta accumulation in studies. Additionally, therapies targeting amyloid-beta production, such as γ-secretase inhibitors, though not yet robustly effective, remain an area of active research.

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Semaglutide for Alzheimer's Disease

Phase 3

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from visit 3 (week 4) to end of treatment (week 64)

Awards & highlights

Pivotal Trial

Summary

This trial is testing if semaglutide, a medicine for diabetes and weight loss, can help people with Alzheimer's disease. The study will last over a year, with participants receiving the medicine through regular injections.

Who is the study for?

This trial is for men and women aged 55-75 with mild cognitive impairment or mild dementia due to Alzheimer's, confirmed by specific criteria. They must be on a stable dose of Alzheimer's medication for over 90 days and show amyloid presence in the brain. People with significant brain disease, autoimmune diseases, recent vaccinations, or use of immune-modifying drugs can't participate.

What is being tested?

The study tests Semaglutide's effects on the immune system and biological processes in Alzheimer's patients. Initially, participants are randomly given either Semaglutide or a placebo for 12 weeks; afterwards, all receive Semaglutide for 52 weeks. The medicine is administered weekly via an injection pen by a study partner.

What are the potential side effects?

While not specified here, common side effects of Semaglutide may include digestive issues like nausea or diarrhea, potential risk of low blood sugar levels (hypoglycemia), headaches, fatigue and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from visit 3 (week 4) to end of treatment (week 64)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from visit 3 (week 4) to end of treatment (week 64)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from visit 3 (week 4) to end of treatment (week 64) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in gene expression assessed by scRNAseq (cells in blood)

Change in gene expression assessed by single-cell ribonucleic acid sequencing (scRNAseq) (cells in cerebrospinal fluid [CSF])

Secondary study objectives

Number of treatment emergent adverse events (TEAEs)

Weekly average semaglutide concentration (Cavg) based on population pharmacokinetic (PK) analysis

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Study intervention period 1Experimental Treatment2 Interventions

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).

Group II: Study intervention period 2Placebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Semaglutide

2021

Completed Phase 4

~5160

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Alzheimer's Disease include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby enhancing communication between nerve cells. NMDA receptor antagonists regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Semaglutide, a GLP-1 receptor agonist, is being studied for its potential neuroprotective effects, including reducing inflammation and oxidative stress, and improving neuronal function. These mechanisms are crucial as they aim to slow cognitive decline and improve the quality of life for Alzheimer's patients by targeting different pathways involved in the disease's progression.