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Donanemab for Alzheimer's Disease
Study Summary
This trial is testing whether the study drug donanemab is safe and effective in Alzheimer's disease patients and whether it can be assessed through video Scale.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have previously taken part in a study for a drug called donanemab, like the TRAILBLAZER-ALZ study, where neither you nor the researchers knew if you were receiving the real drug or a placebo.You have received treatment with a specific type of medication or vaccination that targets amyloid proteins in a previous study.My Alzheimer's medication has been the same for the last 30 days.You have previously participated in a trial for a drug called donanemab, where neither you nor the researchers knew whether you were receiving the drug or a placebo.You cannot undergo PET or MRI imaging due to a medical condition.I have difficulty with blood draws or IV access.I do not have any serious illnesses that could affect the study results.
- Group 1: Part B Donanemab
- Group 2: Part A Validation of Remote Scale Assessments
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is admission to this study open to persons who have achieved their majority?
"This medical study is enrolling patients over the age of 60, up to a maximum of 90 years old."
How widely distributed is this clinical research within the United States?
"The Banner Sun Health Research Institute in Sun City, Synexus Clinical Research US, Inc. in Orlando and Stedman Clinical Trials in The Villages are amongst the 33 locations currently operating for this study."
Is there a possibility for me to participate in this medical research?
"This dementia research endeavor is looking to include 90 individuals, ranging from age 60 to 90. In order to be eligible for the trial, applicants must have had no changes in their AD regimen as well as any medications that might influence cognition for at least one month before randomization and must possess a designated study partner."
Have prior studies demonstrated efficacy for this particular therapeutic modality?
"Currently, 4 studies are being conducted in order to assess this particular treatment. Of those trials, three have advanced to phase 3 testing. The vast majority of the research is located in Irving Texas yet 685 medical sites globally are conducting similar investigations."
Is this an original research endeavor?
"Research on this medication has been ongoing since 2020, spearheaded by Eli Lilly and Company's first clinical trial involving 1800 participants. This drug was eventually approved for Phase 3 use in the same year. Currently, 4 studies are actively running across 335 cities and 9 nations."
Is this treatment reliably secure for individuals?
"Given the Phase 2 status of this therapy, Power assessed its safety with a score of two due to limited data on efficacy."
How many individuals have been enrolled in this research trial thus far?
"This trial is not currently taking on new patients. It was initially posted in November of 2020 and most recently updated in May 2022. On the other hand, if you are researching for alternative studies related to dementia, there are 1099 active trials with 4 pertinent to this treatment that are open for recruitment."
What are the projected results of this medical experiment?
"The primary evaluation criterion of this one-month trial is to explore the connection between VTC and onsite assessments for Alzheimer's disease Assessment Scale - Cognitive Subscale (ADAS-Cog13). Secondary measures include changes in baseline MMSE scores, brain volume as measured by volumetric magnetic resonance imaging (vMRI), and number of participants with anti-donanemab antibodies. The total score range of the MMSE instrument ranges from 0 to 30, lower scores denoting greater impairment."
Are there any current opportunities for individuals to participate in this experiment?
"This clinical trial has reached its recruitment quota and is no longer accepting patients, with the first posting date of November 23rd 2020, and last update on May 25th 2022. For those still looking for trials to join, there are currently 1099 studies related to dementia that are actively recruiting participants as well as 4 corresponding trials focusing on this treatment approach."
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