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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
Study Summary
This trial will test a diabetes drug, semaglutide, to see if it can help treat Alzheimer's. For 77 weeks, participants will receive either the drug or a placebo. After 12 weeks, all participants will get the drug. Partners help with 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.Check my eligibility
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.See study design
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Number of treatment emergent adverse events (TEAEs)
Weekly average semaglutide concentration (Cavg) based on population pharmacokinetic (PK) analysis
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
2019
Completed Phase 4
~5160
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Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,415,044 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
139,802 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any immune system altering drugs in the last year.I am between 55 and 75 years old.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.My tests show amyloid buildup in my brain.I have been on a stable dose of Alzheimer's medication for over 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Study intervention period 1
- Group 2: Study intervention period 2
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 25 and over being sought to join this experiment?
"This trial necessitates that participants are within the 55 to 75-year age bracket. However, there are 19 trials open for individuals younger than 18 and 527 opportunities available above 65 years old."
Answered by AI
Has the initial phase of this particular experiment been given authorization by the FDA?
"Our team at Power assessed Study intervention period 1's safety to be a 3 due to the multiple layers of evidence that supports its efficacy and security."
Answered by AI
Are there any US-based institutions actively conducting research on this topic?
"This research is presently being executed at 9 sites in areas including Ottawa, Toronto and København Ø. To reduce the amount of travelling required as a participant, it's essential to pick the nearest location available."
Answered by AI
Are there any particular demographics that are more suitable for this experiment?
"Qualified candidates for this study should suffer from Alzheimer's disease and be aged between 55 to 75 years old. Currently, 24 participants are being admitted into the trial."
Answered by AI
Are individuals currently being sought for participation in this experiment?
"Clinicaltrials.gov confirms that this trial, which was initially posted on May 31st 2023 and last modified on May 29th of the same year is not accepting applicants anymore; however, there are 534 other medical trials actively seeking patients at present."
Answered by AI
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