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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
Each subject must have a diagnosis of probable AD dementia according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
Each subject must have a Mini-Mental State Examination (MMSE) score ≥ 15 and ≤ 26 at the screening visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 35 weeks
Awards & highlights

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 below
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You must have been diagnosed with probable Alzheimer's disease dementia according to specific criteria from a national organization.
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You need to score between 15 and 26 on a memory and thinking test.
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You must be between 55 and 85 years old when you get checked before the study starts.

DARZAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~35 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With an Improvement of ≥ 4 Points on the ADAS-cog/11
Secondary outcome measures
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 more

Side effects data

From 2023 Phase 2 trial • 16 Patients • NCT04070378
78%
Urticaria
44%
Headache
44%
Infusion reaction; urticarial rash
22%
diarrhea
22%
Difficulty breathing
11%
Weight loss
11%
fever
11%
Fall
11%
Intermittent nausea/upset stomach
11%
Burn on lower back
11%
Supraventricular tachycardia
11%
Runny nose/itchy eyes
11%
Increased agitation
11%
COVID-19 pneumonia
11%
Intermittent palpitations
11%
Insomnia
11%
UTI
11%
cough
11%
Dog bite
11%
Vaccine reaction
11%
Elevated Liver Transaminases
11%
Overactive bladder
11%
Lower back pain/pull
11%
Brief transient unresponsiveness
11%
Floaters
11%
Repetitive sneezing
11%
Scratchy throat
11%
Increased sleepiness
11%
Bilateral cheek, ear, chin erythematous hives with mild swelling and itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Treatment

DARZAD 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
157 Previous Clinical Trials
579,656 Total Patients Enrolled

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04070378 — Phase 2
Alzheimer's Disease Research Study Groups: Open-label Treatment
Alzheimer's Disease Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT04070378 — Phase 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04070378 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~3 spots leftby Mar 2025