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Daratumumab for Alzheimer's Disease (DARZAD Trial)
DARZAD Trial Summary
This trial is testing whether daratumumab, an antibody that targets a protein involved in the progression of Alzheimer's disease, can improve cognition in patients with mild to moderate Alzheimer's.
DARZAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDARZAD Trial 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 2 trial • 16 Patients • NCT04070378DARZAD Trial Design
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Who is running the clinical trial?
Media Library
- You have a score higher than 4 on a test related to ischemic (lack of blood flow) issues in the brain.You have had a stroke in the past, or the screening MRI shows something important according to the doctor.You have a different significant neurological disorder other than probable Alzheimer's disease.You have received certain types of antibodies for treating amyloid-beta or tau protein within the last year.You have had problems with alcohol or drug addiction in the past 5 years.You have a positive hepatitis C antibody blood test.You have tested positive for HIV.Your kidneys are not able to filter blood well, with a clearance less than 30 mL per minute.You are currently taking or are expected to need blood thinning medication.You are taking or may need to take more than 325 mg of aspirin every day.You must have been diagnosed with probable Alzheimer's disease dementia according to specific criteria from a national organization.You need to score between 15 and 26 on a memory and thinking test.You have a history of asthma or chronic lung disease.You need to have a positive amyloid PET scan showing specific brain changes. This scan can be done during the screening period or previously, as long as the doctor approves it.You have had a heart attack, unstable angina, stroke, or similar conditions and needed medical treatment for them within the last 6 months.You have evidence of current or past hepatitis B virus infection based on blood tests.You had any type of cancer, except for certain skin, cervical, or prostate cancers, within the 2 years before the screening visit.You have a low platelet count, less than 50,000 per microliter at the screening visit.You have had an allergic reaction to dexamethasone, diphenhydramine, acetaminophen, montelukast, or acyclovir in the past.Your blood tests must show no important problems with your blood cells, blood clotting, metabolism, thyroid, and vitamin B12 levels.You have a severe and unstable mental health condition like schizophrenia, bipolar disorder, or severe depression. If you have a certain level of depression, you'll be checked by a healthcare professional to see if you can still join the trial.You have received a vaccine targeting amyloid-beta or tau protein.You have taken certain medications that weaken the immune system in the past 2 months.You must be between 55 and 85 years old when you get checked before the study starts.You need to have a specific kind of brain scan called MRI that confirms a diagnosis of AD.
- Group 1: Open-label Treatment
- 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
To what extent is this clinical experiment recruiting volunteers?
"Affirmative. Per the information available on clinicaltrials.gov, this research is currently enrolling subjects; it was initially publicized on November 6th 2019 and most recently updated on November 16th 2021. The investigation requires 15 participants to be recruited across 1 medical site."
How has Daratumumab Injection been tested in past clinical investigations?
"Currently, 140 trials for Daratumumab Injection are being conducted globally. 26 of those studies occupy Phase 3 and 5561 clinical sites across the world have taken part in its research. The majority of these tests hail from Harrison, New york."
What is the typical purpose of employing Daratumumab Injection?
"Daratumumab Injection is a biological response modifier that can be used to treat multiple myeloma, even when it has become refractory or relapsed. It may also help with cell transplants."
Could I be a potential participant in this scientific experiment?
"This medical trial is seeking 15 individuals aged 55-85 that have been medically diagnosed with Alzheimer's disease. Necessary criteria for eligibility includes: a diagnosis of probable AD dementia according to NIA-AA standards, normal physical and neurological examination results, MMSE score between 15-26, MRI scan confirming the presence of AD., amyloid PET scan (or previously performed acceptable version), stable cholinesterase inhibitor/memantine dosage for 12 weeks prior to screening, reliable study partner present 3 days/week minimum 6 waking hours/week duration of trial., no clinically significant abnormal laboratory test results at screening visit., postmenopausal"
Does this clinical research endeavor have any current openings?
"That is correct. Clinicaltrials.gov confirms the active recruitment of participants for this clinical trial, which was first made available on November 6th 2019 and updated on November 16th 2021. This particular medical study requires 15 patients to be enrolled from a single site."
Has the Daratumumab Injection been sanctioned by the FDA?
"Due to limited efficacy data, Daratumumab Injection was assigned a safety score of 2 on our risk assessment scale."
Is the minimum age for recruitment in this experiment set at 25 or above?
"As outlined in the inclusion criteria of this trial, only those aged 55 to 85 may enroll. 25 studies are open for minors and 674 trials offer care to seniors."
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