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Lecanemab for Alzheimer's Disease
Study Summary
This trial will test whether lecanemab is better than placebo at improving cognition and reducing brain amyloid accumulation in people with 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.Trial Design
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Who is running the clinical trial?
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- I have someone who knows about my daily activities and can share this information with the study team.I am using or agree to use birth control as required.You have any other health problems that, according to the doctor's opinion, need more attention or treatment and may interfere with the study or your safety.My bleeding disorder is not well-controlled, with low platelets or high INR.I cannot have an MRI due to a pacemaker, metal implants, or other MRI unsafe devices.You do not have any signs of dementia according to a test called Clinical Dementia Rating (CDR).I am 55-64 with a family history of early dementia, carry the APOE4 gene, or have high brain amyloid levels.I am between 55 and 80 years old and have test results showing intermediate or high brain amyloid levels.I haven't had cancer, except for certain skin cancers or treated prostate cancer, in the last 3 years.I have had serious thoughts about or attempts at suicide in the past 6 months or have been treated for suicidal behavior in the last 5 years.I have a family history of early dementia, carry the APOE4 gene, or have high brain amyloid levels.My immune system disease is not well-controlled or needs strong medication.I am between 55 and 80 years old and have test results showing intermediate or high levels of brain amyloid.I am currently pregnant or breastfeeding.I am HIV positive.You have no signs of dementia according to a test called Clinical Dementia Rating (CDR) at the time of screening.I have had a stroke, TIA, or seizures in the last year.I am not taking any medications that are not allowed in the study.
- Group 1: A3 Trial: Placebo
- Group 2: A45 Trial: Placebo
- Group 3: A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg
- Group 4: A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg
- 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 include people who are not yet 75 years old?
"This trial is only for patients aged 55 to 80. Out of the 25 trials taking place for people under 18 and 649 trials involving seniors, this is the one that meets your age specifications."
Can you provide more context on Lecanemab's past medical research?
"The first lecanemab clinical trials were completed in 2012 at Facility #1. As of today, a total of 18280 have been completed with 3 more ongoing. The majority of these studies are being conducted from Lexington, Kentucky."
Has the FDA approved Lecanemab for public use?
"Lecanemab has undergone Phase 3 trials, meaning that not only is there some evidence of its efficacy, but also that it has been through multiple rounds of testing for safety. Consequently, our team rates its safety as a 3."
To what demographic does this research apply?
"This clinical trial is looking for 1400 individuals aged 55-80 who have Alzheimer's disease. The most notable criteria for applicants are as follows: being male or female, having a first degree relative diagnosed with dementia onset before age 75, or known to possess at least 1 apolipoprotein E4 variant (APOE4) allele. Other requirements include a Global Clinical Dementia Rating (CDR) score of 0 at screening, a Mini Mental State Examination score greater than or equal to 27 (with educational adjustments) at screening, and a Wechsler Memory Scale-Revised Logical Memory subscale II (W"
How many different areas are coordinating this research?
"82 sites are running this trial at the moment, with locations in Lexington, The Villages, Cleveland and a multitude of other places. If you enroll in the study, it would be best to choose a clinic near you to limit travelling."
What are the origins of this type of drug trial?
"As of right now, there are three ongoing studies for Lecanemab spanning 262 cities and 15 countries. The first study was conducted back in 2012 by Eisai Inc. 856 patients participated in the Phase 2 drug approval process. In the years since 2012, a total of 18280 trials have been completed worldwide."
Are we currently accepting patients for this clinical trial?
"The study, which can be found on clinicaltrials.gov, is still recruiting patients. The listing was first put up on July 14th 2020 with the most recent update being June 14th of this year."
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?
Most responsive sites:
- Case Western Reserve University/University Hospitals: < 48 hours
Average response time
- < 2 Days
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