Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04902703
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Sargramostim — DRUG
    Sargramostim is a granulocyte macrophage colony stimulating factor that will be administered at a dose of 178.57 mcg/m2 per day subcutaneously, 7 days/week, for 24 weeks
  • Saline - placebo comparator — DRUG
    Saline will be administered subcutaneously, 7 days/week, for 24 weeks

Study Details

A medicine that is FDA-approved for bone marrow stimulation (called sargramostim) will be tested for its safety and efficacy in individuals with mild-to-moderate Alzheimer's disease over a six month treatment period.

Key Dates

Start date
Jun 1, 2022
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sargramostim
    178.57 mcg/m2/day subcutaneously 7 days/week for 24 weeks
  • Placebo Comparator: Placebo Control - Saline
    Placebo comparator (saline) subcutaneously 7days/week for 24 weeks

Primary Outcome Measure

Safety as measured by number of Adverse Events (AEs) by body system [ Time Frame: Informed consent to Follow-up Visit (38 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Neurology Research Partners
[email protected]
3037244644

Find similar trials in Aurora, CO

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

Related Studies