Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01409915 |
Recruitment Status :
Completed
First Posted : August 4, 2011
Results First Posted : March 23, 2021
Last Update Posted : June 2, 2021
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Sponsor:
University of Colorado, Denver
Collaborator:
The Dana Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Alzheimer's Disease |
Interventions |
Drug: Sagramostim Drug: Saline -- placebo comparator |
Enrollment | 44 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Sagramostim (Leukine) | Control Group |
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250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. | Saline placebo comparator: subcutaneous injection |
Period Title: Overall Study | ||
Started | 21 | 23 |
Completed | 20 | 20 |
Not Completed | 1 | 3 |
Reason Not Completed | ||
Adverse Event | 0 | 2 |
Withdrawal by Subject | 0 | 1 |
Protocol Violation | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Sagramostim (Leukine) | Control Group | Total | |
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250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. | Saline placebo comparator: subcutaneous injection | Total of all reporting groups | |
Overall Number of Baseline Participants | 20 | 20 | 40 | |
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The analysis population is Per Protocol, with all participants enrolled and randomized in the clinical trial, and who complete the treatment without major breaches in the study protocol.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 20 participants | 20 participants | 40 participants | |
67.10 (6.57) | 70.15 (6.42) | 68.63 (6.59) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 20 participants | 40 participants | |
Female |
12 60.0%
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11 55.0%
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23 57.5%
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Male |
8 40.0%
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9 45.0%
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17 42.5%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race / Ethnicity | Number Analyzed | 20 participants | 20 participants | 40 participants |
White / Caucasian |
20 100.0%
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19 95.0%
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39 97.5%
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Black / African American |
0 0.0%
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1 5.0%
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1 2.5%
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Asian / Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Hispanic / Latino |
0 0.0%
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0 0.0%
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0 0.0%
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Other |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 20 participants | 20 participants | 40 participants |
20 100.0%
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20 100.0%
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40 100.0%
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Education Level (Mean years)
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 20 participants | 20 participants | 40 participants | |
15.70 (2.92) | 15.80 (2.71) | 15.75 (2.78) |
Outcome Measures
Adverse Events
Limitations and Caveats
The main weakness is the small sample size of the study.
More Information
Results Point of Contact
Name/Title: | John O'Shaughnessy, MS, Clinical Research Services Principal Professional |
Organization: | University of Colorado Denver | Anschutz Medical Campus |
Phone: | 3037247924 |
EMail: | john.oshaughnessy@cuanschutz.edu |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT01409915 |
Other Study ID Numbers: |
12-1273 |
First Submitted: | August 2, 2011 |
First Posted: | August 4, 2011 |
Results First Submitted: | February 25, 2021 |
Results First Posted: | March 23, 2021 |
Last Update Posted: | June 2, 2021 |