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Monoclonal Antibodies
Daratumumab for Alzheimer's Disease (DARZAD Trial)
Phase 2
Waitlist Available
Research Sponsored by Marc L Gordon, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing Daratumumab, an antibody medicine, on patients with mild to moderate Alzheimer's disease. The medicine targets harmful immune cells to reduce their damaging effects on the brain.
Eligible Conditions
- Alzheimer's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 35 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With an Improvement of ≥ 4 Points on the ADAS-cog/11
Secondary study objectives
The Number of Subjects Who Are Unchanged or Improved From Baseline on ADAS-cog/12 Score
The Number of Subjects Who Are Unchanged or Improved From Baseline on the ADCOMS
The Number of Subjects Who Are Unchanged or Improved From Baseline on the CDR-SB
+3 moreSide effects data
From 2023 Phase 2 trial • 16 Patients • NCT0407037878%
Urticaria
44%
Headache
44%
Infusion reaction; urticarial rash
22%
Difficulty breathing
22%
diarrhea
11%
Lower back pain/pull
11%
Fall
11%
UTI
11%
Increased sleepiness
11%
Insomnia
11%
Overactive bladder
11%
Vaccine reaction
11%
Repetitive sneezing
11%
Brief transient unresponsiveness
11%
Burn on lower back
11%
Scratchy throat
11%
Weight loss
11%
Bilateral cheek, ear, chin erythematous hives with mild swelling and itching
11%
Supraventricular tachycardia
11%
Dog bite
11%
Elevated Liver Transaminases
11%
fever
11%
COVID-19 pneumonia
11%
cough
11%
Floaters
11%
Increased agitation
11%
Intermittent nausea/upset stomach
11%
Intermittent palpitations
11%
Runny nose/itchy eyes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open-label TreatmentExperimental Treatment1 Intervention
This is an open-label pilot study designed to explore whether daratumumab may have a clinically meaningful effect in patients with mild to moderate Alzheimer's disease. During the treatment phase, eligible subjects will receive daratumumab SC 1800 mg (daratumumab 1800 mg with rHuPH20 30,000 units) subcutaneous infusion over 3-5 minutes (15 mL) once weekly for 8 weeks followed by daratumumab SC 1800 mg every 2 weeks for 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab Injection
2020
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Marc L Gordon, MDLead Sponsor
Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,957 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Open-label Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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