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

Part of paid clinical trials in Manhasset, New York.

Sponsor
Marc L Gordon, MD
Study ID
NCT04070378
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab Injection — DRUG
    Daratumumab SC 1800 mg (daratumumab 1800 mg with rHuPH20 30,000 units) subcutaneous infusion

Study Details

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.

Key Dates

Start date
Nov 6, 2019
Status verified
Nov 2023
Primary completion
Jun 8, 2023
Completion
Aug 15, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label Treatment
    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.

Primary Outcome Measure

Number of Participants With an Improvement of ≥ 4 Points on the ADAS-cog/11 [ Time Frame: 25 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Litwin-Zucker Research CenterManhassetNew York11030-

Find similar trials in Manhasset, NY

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
The Litwin-Zucker Research Center· Manhasset, NY

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