Loading clinical trials...

Study of Daratumumab in Patients With Mild to Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Daratumumab in Patients With Mild to Moderate Alzheimer's Disease

An Open-Label, Pilot Study of Daratumumab SC in Patients With Mild to Moderate Alzheimer's Disease

NCT04070378•Marc L Gordon, MD

Summary

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.

Detailed Description

Daratumumab is a human antibody that targets CD38. It is FDA-approved for the treatment of multiple myeloma, has broad-ranging immunomodulatory effects on nonplasma cells that express CD38, and is able to cross the blood-brain barrier. CD38 expression on CD8+ T-cells is significantly increased in the blood of early AD patients as compared with age-matched controls, and activated T-cells are capable of trafficking into the central nervous system and exerting toxic effects. This study is designed to explore whether treatment with Daratumumab may have a clinically meaningful effect on patients with mild to moderate Alzheimer's disease.

Eligibility

Age

55 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Each subject must be ≥ 55 to ≤ 85 years of age at the screening visit.
•2. Each subject must have a diagnosis of probable AD dementia according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.
•3. Each subject must have a Mini-Mental State Examination (MMSE) score ≥ 15 and ≤ 26 at the screening visit.
•4. Each subject must have a Magnetic Resonance Imaging (MRI) scan performed during the screening period that is consistent with a diagnosis of AD.
•5. Each subject must have a positive amyloid Positron Emission Tomography (PET) scan, either performed during the screening period, or previously performed provided that the scan and result are considered acceptable by the investigator.
•6. If the subject is receiving a cholinesterase inhibitor (donepezil, rivastigmine, or galantamine) and/or memantine, the dose must have been stable for at least 12 weeks before the screening visit, and the subject must be willing to remain on the same dose for the duration of the trial.
•7. Each subject must have a study partner who is reliable and competent. The study partner must have a close relationship with the subject, have face to face contact at least 3 days/week for a minimum of 6 waking hours/week, and be willing to accompany the subject to all required study visits.
•8. Each subject must have no clinically significant abnormal laboratory test results \[complete blood count (CBC), prothrombin time (PT)/international normalized ratio (INR), activated partial thromboplastin time (APTT), comprehensive metabolic panel (CMP), thyroid stimulating hormone (TSH), and vitamin B12 level\] at the screening visit.
•9. Each subject must have results of a physical and neurological examination and vital signs within normal limits or clinically acceptable to the investigator at the screening visit.
•10. If female, the subject must be postmenopausal defined as: No menses for 12 or more months without an alternative medical cause OR permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).

Exclusion Criteria

•1. The subject has a Rosen-modified Hachinski Ischemia Score \> 4 at the screening visit.
•2. The subject has a known history of stroke or evidence from screening MRI that is clinically significant in the investigator's opinion.
•3. The subject has evidence of a clinically relevant neurological disorder other than probable AD at the screening visit, including: vascular dementia, Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, progressive supranuclear palsy, corticobasal degeneration, amyotrophic lateral sclerosis, Huntington's disease, multiple sclerosis, mental retardation, hypoxic cerebral damage, or head trauma with loss of consciousness that led to persistent cognitive deficits.
•4. The subject has evidence of a clinically relevant or unstable psychiatric disorder, based on DSM-5 criteria, including schizophrenia or other psychotic disorder, bipolar disorder, delirium, or major depression. (Major depression in remission is not exclusionary.) A score on the 15-item Geriatric Depression Scale (GDS) of 5 or more requires an assessment by an appropriate health care professional to evaluate for the presence of major depression. Subjects with a score of 5 or more who are not diagnosed with major depression following such an assessment may be included in the trial.
•5. The subject has a history of alcoholism or drug dependency/abuse within the last 5 years before screening.
•6. The subject has been treated with any investigational product within 60 days or 5 half-lives (whichever is longer) prior to the screening visit.
•7. The subject has been treated with anti-amyloid-beta or anti-tau protein monoclonal antibodies within one year prior to the screening visit.
•8. The subject has been treated with an active vaccine targeting amyloid-beta or tau protein.
•9. The subject has received a live/live-attenuated bacterial or viral vaccine within 3 months prior to the screening visit.
•10. The subject has been treated with immunosuppressive medications, such as azathioprine, cyclosporine, methotrexate, tacrolimus, or mycophenylate, within 2 months prior to the screening visit.
+18 more criteria

Locations (1)

The Litwin-Zucker Research Center

Manhasset, New York, United States

Key Dates

Start Date

November 6, 2019

Primary Completion Date

June 8, 2023

Completion Date

August 15, 2023

Last Updated

November 14, 2025

Enrollment

ACTUAL participants

Conditions

Alzheimer Disease

Interventions

Daratumumab Injection

DRUG

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

NCT04123314

Depressive SymptomsDepression+2 more

View study

RECRUITINGNA

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

NCT07178210

Alzheimer DiseaseLymphatic Obstruction

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Daratumumab in Patients With Mild to Moderate Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

Longitudinal Early-onset Alzheimer's Disease Study Protocol

A Study of AMDX-2011P in Participants With Alzheimer's Disease