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

NCT04902703 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sargramostim

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

DRUG

Saline - placebo comparator

Saline will be administered subcutaneously, 7 days/week, for 24 weeks

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Alzheimer's Association

    collaborator OTHER

  • Partner Therapeutics, Inc.

    collaborator INDUSTRY

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Huntington Potter, PhD · University of Colorado Alzheimer's and Cognition Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902703 on ClinicalTrials.gov