Phase 2 N=44 Randomized Triple-blind Treatment

Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01409915 ↗

Enrolled (actual)

Serious AEs

4.6%

Results posted

Mar 2021

Primary outcome: Primary: Adverse Events (AEs) by Body System — 5; 2; 6; 5 Adverse Events

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sagramostim (Drug); Saline -- placebo comparator (Drug)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Events (AEs) by Body System	5; 2; 6; 5; 1; 0	—
SECONDARY MMSE (Mini Mental State Examination) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)	17.10; 20.75; 18.55; 20.40; 18.00; 19.90	—
SECONDARY Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment)	43.20; 36.20; 43.54; 36.68; 47.67; 36.33	—

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.

Eligibility Criteria

Inclusion Criteria

age 55 to 85 years;
should have a mild-to-moderate AD diagnosis (MMSE 10-26 inclusive);
should have evidence of elevated cortical amyloid by PET using florbetapir F18 (Amyvid) [i.e. a positive scan], assessed qualitatively according to the Amyvid product label.
if on anti-dementia treatment should be on stable treatment for at least 2 months (i.e. cholinesterase inhibitor and/or Memantine or Axona);
stable on all other medications for at least 30 days prior to screen;
should be fluent in English;
should be physically able to participate by medical history, clinical exam and tests;
should have a study partner to accompany them to scheduled visits.

Exclusion Criteria

clinically relevant arrhythmias;
a resting pulse less than 50;
active cancer other than non-melanoma skin cancers;
use of another investigatory drug within 2 months of screening;
significant stroke or head trauma by history or MRI;
contraindication for having a MRI;
diagnostic and Statistical Manual of Mental Disorders-IV criteria for a current major psychiatric disorder;
sensitivity to yeast or yeast products;
impaired kidney function as measured by a Glomerular Filtration Rate less than 60 milliliters/min;
preexisting fluid retention, pulmonary infiltrates, or congestive heart failure;
history of moderate-to-severe lung disease;
history of moderate-to-severe liver disease;
pregnant women, or any women who feel they are likely to become pregnant during the study;
prisoners.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01409915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.