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Semaglutide for Early Alzheimer's Disease
Study Summary
This trial is testing whether semaglutide has a positive effect on early Alzheimer's disease by comparing it to a placebo. There will be 17 clinic visits and 1 phone call with the study doctor, and various tests and scans will be performed. The study will last for up to 173 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 3 trial • 458 Patients • NCT03015220Trial Design
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- A brain scan shows signs of specific types of strokes confirmed by a specialist.I have a neurological disorder that is not mild cognitive impairment or mild Alzheimer's.You have a serious mental health condition that is not stable.I have mild dementia, with some difficulty in daily activities.My tests show amyloid buildup in my brain.Your MMSE score is 22 or higher.You scored 22 or higher on the Mini-Mental State Examination.A brain MRI or CT scan shows a serious brain condition confirmed by a specialist.My Alzheimer's medication dose has been stable for 3 months.A brain scan shows significant small blood vessel problems confirmed by a specialist.I am between 55 and 85 years old.Your memory test score is 85 or lower.You have mild memory or thinking problems related to Alzheimer's disease according to specific medical guidelines.I have mild dementia, with some difficulty in daily activities.Your memory test score is 85 or lower on the RBANS test.
- Group 1: Placebo (semagludtide)
- Group 2: Oral Semaglutide
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there other examples of research done on Semagludtide?
"Semagludtide was first trialed in 2018 at Novo Nordisk Investigational Site. To date, there have been 123 completed studies. There are presently 59 studies underway, a considerable number of which are taking place in Phoenix, Arizona."
What are some common conditions that doctors often treat with Semagludtide?
"Semagludtide can help patients struggling with weight management, calorie restriction, and lack of exercise."
Is there a history of negative side effects with Semagludtide?
"Semagludtide was given a safety score of 3. This is because it is a phase 3 trial, meaning that there is both efficacy and safety data available from multiple rounds of testing."
Is the age limit for this clinical trial set at 75 years or younger?
"This particular study is only for patients aged 55 to 85 years old. In contrast, there are 26 trials for people who are under 18 and 595 trials for patients that are over 65."
What makes this clinical experiment innovative?
"Semagludtide has been under medical scrutiny since 2018. The first trial was completed in that same year and was sponsored by Novo Nordisk A/S. The trial included 1387 patients. Semagludtide received Phase 4 drug approval after the first study in 2018. As of now, there are 59 active trials in 711 cities and 55 countries."
What is the projected intake for this experiment?
"That is correct, an updated posting on clinicaltrials.gov shows that this research is recruiting patients. The study was first published on May 18th, 2021 and the most recent edit was on March 30th, 2022. Up to 1840 patients can be enrolled at 66 sites."
Are people with the disease currently being enrolled in this research program?
"The most recent information available on clinicaltrials.gov suggests that this study is still recruiting patients. The trial was initially posted on May 18th, 2021 and was updated as recently as March 30th, 2022."
To whom does this opportunity for testing extend?
"This clinical trial is looking for 1840 participants aged 55-85 who have Alzheimer's disease. Patients must also meet the following criteria: MMSE (Mini-Mental State Examination) greater than or equal to 22, CDR (Clinical Dementia Rating) global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home & hobbies, community affairs) Or CDR global score of 1.0, RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index score of below or equal to"
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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How responsive is this trial?
Typically responds via
Most responsive sites:
- Novo Nordisk Investigational Site: < 48 hours
Average response time
- < 2 Days
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