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Donanemab for Alzheimer's Disease
Study Summary
This trial will test a new drug, donanemab, for safety and effectiveness in people with early Alzheimer's disease.
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 2023 Phase 3 trial • 148 Patients • NCT05108922Trial Design
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Who is running the clinical trial?
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- I am willing to do cognitive tests during screening.Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.My tests show early signs of Alzheimer's disease.I do not have Alzheimer's or dementia.A telephone interview for cognitive status - modified (TICS-M) score reflective of intact cognitive functioning.I am between 65 and 80 years old.I am willing and able to have an MRI scan.You can only participate in this study if you are not already taking part in another research study.Have any of your family members ever had Alzheimer's or dementia?
- Group 1: Donanemab
- Group 2: Placebo
- 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
Has Donanemab received official government sanction for medical use?
"Donanemab has received a score of 3 for safety. This is due to the fact that it is a Phase 3 trial, which means that there is evidence supporting its efficacy as well as data from multiple rounds of testing affirming its safety."
Are there comparable treatments to Donanemab that have undergone clinical trials?
"At the moment, there are four ongoing clinical trials studying donanemab. Three of those studies are in phase three. Although most of the trials for donanemab are taking place in Milford, Ohio, there are a total of 684 locations running these studies."
Are people still being accepted into the program?
"The latest information from clinicaltrials.gov does show that this trial is still enrolling patients. The initial posting was on 8/27/2021, with the most recent update being 11/10/2022. There are 3300 positions open across 100 different medical facilities."
How many people can join this research project?
"3300 participants are required to successfully run this clinical trial. The sponsor, Eli Lilly and Company, has selected different medical sites across the country to help with recruitment. For example, Option Care - Sacramento in Sacramento, California and Care Access - Beverly Hills in Beverly Hills, Texas will both be participating."
Are there many locations where this research project is taking place in town?
"Currently, there are 100 clinical trial sites operating across the nation, with locations in cities such as Sacramento, Beverly Hills, and Houston."
For this particular test, are senior citizens welcome?
"This particular study is for patients aged between 65 and 80 years old. Out of the 557 clinical trials for patients over 65, this one is just 1/23rds."
Do we have any other examples to compare this too?
"Donanemab has a short clinical history, with the first trial being conducted in 2020. This initial study was sponsored by Eli Lilly and Company. After this 1800-person Phase 1 study, Donanemab received approval for further testing. Currently, there are 4 active trials involving 334 cities across 9 nations."
What are the Participant Inclusion Criteria for this research project?
"The eligibility criteria for this study include being 65-80 years old and having a diagnosis of Alzheimer's disease. The clinical trial is looking to enroll 3300 total patients."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Tilda Research - USAL 45: < 48 hours
- Accellacare - DuPage: < 48 hours
- Accellacare - Winston-Salem: < 48 hours
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