CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Sagramostim +1 moredrug
Likely dose
Sagramostim 250 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01409915
NCT01409915Phase 2Completed
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Pilot Phase 2 Trial of the Safety & Efficacy of Granulocyte-Macrophage Colony-Stimulating Factor (Leukine®) in the Treatment of Alzheimer's Disease

University of Colorado, Denver·interventional·Posted Aug 4, 2011·Updated Jun 2, 2021

In Brief

A Phase 2 clinical trial evaluating Sagramostim and Saline -- placebo comparator for Alzheimer's Disease. Completed, enrolled 44 participants across 1 site.

Detailed Summary

A medicine that is FDA-approved for bone marrow stimulation (called Leukine) will be tested for its ability to be tolerated by Alzheimer's disease patients and potentially to improve their memory.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
CollaboratorsThe Dana Foundation

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 4, 2011
Enrollment StartMar 1, 2011
Primary CompletionDec 9, 2019
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 14.9 years ago

Interventions

Sagramostimdrug

5 subjects 250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. Data and Safety Monitoring Board will then review data and recommend whether to continue at the same current recommended dose for additional subjects or to reduce the dose by half if excessive leukocytosis occurs

Saline -- placebo comparatordrug

subcutaneous injection