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Donanemab for Alzheimer's Disease
Study Summary
This trial will compare two drugs for their ability to clear amyloid plaques in people with early Alzheimer's Disease.
- Alzheimer's Disease
- Mild Cognitive Impairment
Timeline
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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- The investigator believes that the participant has adequate literacy, vision, and hearing to complete neuropsychological testing.You or someone close to you has noticed a decline in your memory over a period of at least 6 months.You have mild to moderate dementia, as determined by a clinical assessment called the Clinical Dementia Rating (CDR) scale.You have a serious neurological condition that affects your brain, such as dementia, Parkinson's disease, or a history of stroke or seizures.You have previously participated in a study focused on treating Amyloid beta with immunotherapy, or you are currently participating in such a study.You have been treated with donanemab or aducanumab in the past or are currently receiving treatment with them.You are allergic to donanemab or aducanumab, or any of the ingredients in the medication.You have a history of bleeding disorder or take medications that prevent blood from clotting, except for low-dose aspirin.You or someone who knows you well has noticed a consistent decline in your memory over the past 6 months or longer.You have had serious allergic reactions to multiple medications in the past, or severe skin reactions after taking medication.You have a mild cognitive impairment or early-stage dementia, as determined by a specific assessment called the Clinical Dementia Rating (CDR).
- Group 1: Donanemab
- Group 2: Aducanumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does this research represent a new development in the field?
"5 clinical trials are underway for the use of Donanemab. The first trial was in 2020 and sponsored by Biogen. It had 1696 participants and completed Phase 3 drug approval stage. There have been a total of 8 studies conducted since then, spanning 444 cities and 22 countries."
Given my current health condition, can I join this experiment?
"To participate in this clinical research, 200 individuals who have alzheimer disease and are between 50 to 85 years old are needed."
How many people total are involved in this research project?
"This trial is not currently open for enrollment. The listing was first posted on November 16th, 2021 and was last updated on November 9th, 2022. There are 1012 other trials seeking patients with Alzheimer's disease and 5 studies involving Donanemab that are still open to new participants."
Are there any spaces remaining in this trial for new participants?
"Unfortunately, this particular study is no longer actively recruiting patients. The clinical trial was first posted on November 16th 2021 but the most recent update occurred on November 9th, 2022. There are presently 1012 studies enrolling patients with Alzheimer's disease and 5 trials for Donanemab that are still looking for participants."
What other research has there been surrounding Donanemab?
"Donanemab is being trialled in 5 studies, 4 of which are Phase 3 clinical trials. The majority of these are taking place in Sacramento, California; however, there are 977 total research locations across the world."
Please describe the number of facilities where this research is taking place.
"To facilitate patient participation, this trial is enrolling at 36 sites located across the country; from Carlsbad to Sherman Oaks to Las Vegas. You may want to choose a location close to you in order to limit travel."
Has Donanemab undergone the FDA's stamp of approval?
"We believe that Donanemab is safe based on its Phase 3 status--there is some evidence of efficacy and the medication has gone through multiple rounds of safety testing."
Does this research experiment have an age limit?
"This particular clinical trial is only for patients who are between the ages of 50 and 85. In comparison, there are 44 clinical trials underway for people under 18 years old and 971 for senior citizens aged 65 and up."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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