Trial · NCT01409915
Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
NCT01409915, Phase 2, Completed, University of Colorado, Denver; results first posted 2021-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease. Trials, record NCT01409915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01409915
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety & Efficacy of Leukine® in the Treatment of Alzheimer's Disease
- NCT number
- NCT01409915
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Alzheimer's Disease
- Interventions
- Sagramostim, Saline -- placebo comparator
- First posted
- 2011-08-04
- Last updated
- 2021-06-02
- Results first posted
- 2021-03-23
- Limitations and caveats
- The main weakness is the small sample size of the study.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events (AEs) by Body System | 20 weeks (From Consent to Follow-up 2) | Count of AE's from Consent to Follow-up 2 within a safety analysis set consisting of all participants who were enrolled and randomized and who received at least one injection of sargramostim or placebo |
| 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) | From Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | Mini-Mental State Examination (MMSE) is a brief psychometric instrument developed to assess cognitive function in elderly populations. It is a standard assessment used by all NIH Alzheimer's Disease Centers (ADCCs and ADRCs) to identify and monitor individuals with AD. The range for scores in the MMSE is from 0 to 30, with lower scores indicating greater impairment. |
| 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) | Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog13). The ADAS-Cog13 is the most popular cognitive testing instrument used in clinical trials of nootropics (drugs or agents that improve cognitive function). It consists of 13 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities, which are often referred to as the core symptoms of AD. Score ranges from 0-85, with a higher score representing more severe impairment |
| Other | Alzheimer's Disease Cooperative Study -Activities of Daily Living Inventory (ADCS-ADL) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment) | Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | The ADCS-ADL is a caregiver/study partner rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 implies full functioning with no impairment. The ADCS-ADL assesses functional capacity across a wide spectrum of severity |
| Other | Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment) | Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | The CDR is a study partner/caregiver and participant based interview to assess changes in domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated as 0 (no dementia), 0.5 (uncertain dementia), 1 (mild dementia), 2 (moderate dementia), or 3 (severe dementia). The Sum of Boxes score (CDR-SB) score was tallied for each administration using the rules from the Washington University Knight ADRD scoring algorithm. Scores range from 0-18. The higher the score, the worse the impairment. |
| Other | Trail Making Test - Part A (TMT-A) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment) | Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | The Trail Making Test- part A (TMT-A) is a assessment of psychomotor speed and is a timed test in which participants must connect a series of numbers randomly placed on a page. Time range is between 0 and 150 seconds, with higher score representing worse performance. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adverse Events (AEs) by Body System | 20 weeks (From Consent to Follow-up 2) | Safety analysis set (SAS), all participants enrolled and randomized and who received at least one injection of sargramostim or placebo | Adverse Events | NUMBER |
| 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) | From Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | 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. | score on a scale | MEAN |
| 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) | Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | 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. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Alzheimer's Disease Cooperative Study -Activities of Daily Living Inventory (ADCS-ADL) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment) | Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | 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. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment) | Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | 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. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Trail Making Test - Part A (TMT-A) From Baseline to End of Treatment (3 Weeks), Follow-Up 1 (45 Days Post Treatment) and Follow-Up 2 (90 Days Post Treatment) | Baseline to End of Treatment (3 weeks), Follow-Up 1 (45 days post treatment) and Follow-Up 2 (90 days post treatment) | 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. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adverse Events (AEs) by Body System | Sagramostim (Leukine) | Cardiovascular AE | 5 | Adverse Events | |
| Adverse Events (AEs) by Body System | Control Group | Cardiovascular AE | 2 | Adverse Events | |
| Adverse Events (AEs) by Body System | Sagramostim (Leukine) | Constitutional | 6 | Adverse Events | |
| Adverse Events (AEs) by Body System | Control Group | Constitutional | 5 | Adverse Events | |
| Adverse Events (AEs) by Body System | Sagramostim (Leukine) | Dental | 1 | Adverse Events | |
| Adverse Events (AEs) by Body System | Control Group | Dental | 0 | Adverse Events | |
| Adverse Events (AEs) by Body System | Sagramostim (Leukine) | Dermatological | 16 | Adverse Events | |
| Adverse Events (AEs) by Body System | Control Group | Dermatological | 5 | Adverse Events | |
| Adverse Events (AEs) by Body System | Sagramostim (Leukine) | ENT | 2 | Adverse Events | |
| Adverse Events (AEs) by Body System | Control Group | ENT | 0 | Adverse Events |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sagramostim (Leukine) | 21 | |
| Overall Study | STARTED | Control Group | 23 | |
| Overall Study | COMPLETED | Sagramostim (Leukine) | 20 | |
| Overall Study | COMPLETED | Control Group | 20 | |
| Overall Study | NOT COMPLETED | Sagramostim (Leukine) | 1 | |
| Overall Study | NOT COMPLETED | Control Group | 3 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Sagramostim (Leukine) | 2 | 21 | |
| other | Fatigue | General disorders | Control Group | 4 | 23 | |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Sagramostim (Leukine) | 9 | 21 | |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Control Group | 5 | 23 | |
| other | Rash | Skin and subcutaneous tissue disorders | Sagramostim (Leukine) | 3 | 21 | |
| other | Rash | Skin and subcutaneous tissue disorders | Control Group | 0 | 23 | |
| other | Nausea | Gastrointestinal disorders | Sagramostim (Leukine) | 3 | 21 | |
| other | Nausea | Gastrointestinal disorders | Control Group | 1 | 23 | |
| other | Diarrhea | Gastrointestinal disorders | Sagramostim (Leukine) | 2 | 21 | |
| other | Diarrhea | Gastrointestinal disorders | Control Group | 3 | 23 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sagramostim (Leukine) | 0 | 21 |
| Total, all-cause mortality | Control Group | 0 | 23 |
| Total, other adverse events | Sagramostim (Leukine) | 19 | 21 |
| Total, other adverse events | Control Group | 20 | 23 |
| Total, serious adverse events | Sagramostim (Leukine) | 1 | 21 |
| Total, serious adverse events | Control Group | 1 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sagramostim (Leukine) vs Control Group: deaths from any cause | Trial comparisons |
| Sagramostim (Leukine) vs Control Group: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Trail Making Test A | Other outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01409915
GET https://conductscience.org/api/trials/v1/NCT01409915/results?page=2