Semaglutide for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am between 55 and 75 years old.

Clinical dementia rating (CDR) global score of 0.5 or 1 at screening (visit 1)

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

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Exclusion Criteria

I haven't taken any immune system altering drugs in the last year.

I have not received any vaccines within 4 weeks before my first visit or won't until after visit 5.

I have an autoimmune disease like lupus or rheumatoid arthritis.

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Treatment Details

Interventions

Placebo (Other)
Semaglutide (Glucagon-like peptide-1 receptor agonist)

Trial OverviewThe 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.

Participant Groups

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.