Trial · NCT04902703
Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease
NCT04902703, Phase 2, Recruiting, University of Colorado, Denver
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease. Trials, record NCT04902703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04902703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease
- NCT number
- NCT04902703
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 42 participants, estimated
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Alzheimer Disease
- Interventions
- Sargramostim, Saline - placebo comparator
- First posted
- 2021-05-26
- Last updated
- 2026-04-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety as measured by number of Adverse Events (AEs) by body system | Informed consent to Follow-up Visit (38 weeks) | The safety of sargramostim will be assessed through number of adverse events (AEs) by body system from consent to follow-up within a safety analysis set consisting of all individuals who were enrolled and and randomized and who received at least one injection of sargramostim or placebo. |
| Secondary | Mini-Mental State Examination | Baseline to End of Treatment, Follow-up (30 weeks) | 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. |
| Other | Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog13) | Baseline to End of Treatment, Follow-up (30 weeks) | The ADAS-Cog13 measures the severity of the most important symptoms of AD. and 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. The score ranges form 0-85, with higher score denoting worse performance |
| Other | Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) | Baseline to End of Treatment, Follow-up (30 weeks) | 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). Range is 0-18. Higher scores denote worse functioning |
| Other | Trail Making Test - Part A (TMT-A) | Baseline to End of Treatment, Follow-up (30 weeks) | Psychomotor speed will be assessed by the Trail Making Test-A, a timed test in which participants must connect a series of numbers randomly placed on a page. Time range is 0-150 seconds, with a higher time denoting worse performance |
| Other | Alzheimer's Disease Cooperative Study -Activities of Daily Living Inventory (ADCS-ADL) | Baseline to End of Treatment, Follow-up (30 weeks) | 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. |
| Other | Montreal Cognitive Assessment (MoCA) | Baseline to End of Treatment, Follow-up (30 weeks) | The Montreal Cognitive Assessment (MoCA) is a brief, assessment developed for detection and tracking of cognitive impairment and is sensitive for detecting Alzheimer's disease. Measuring multiple domains, it is commonly used in both clinical and research settings, and is well validated, with a range of scores from 0-30. |
| Other | Neuropsychiatric Inventory (NPI) | Baseline to End of Treatment, Follow-up (30 weeks) | Neuropsychiatric Inventory (NPI) is a study partner/caregiver interview to assess any changes in neuropsychiatric status in such domains as hallucinations, delusions, agitation, depression, anxiety, disinhibition, apathy and aberrant motor behaviors. It assesses presence of symptoms, and scores by severity X frequency (Range 0-12 in each symptom category), and caregiver distress (Range 0-5). The higher the scores, the the greater the presence of the impact of the symptom. |
| Other | Verbal Fluency | Baseline to End of Treatment, Follow-up (30 weeks) | Verbal fluency (producing words that start with a specific letter of the alphabet, also known as letter fluency) is a timed test where a participant produces as many works as they can in 60 seconds. The more correct words that a participant produces, the higher the score. |
| Other | Semantic Fluency | Baseline to End of Treatment, Follow-up (30 weeks) | Semantic fluency (producing words that belong in a category, such as animals, also known as category fluency) is a timed test where a participant produces as many works as they can in 60 seconds within a category. The more correct words that a participant produces, the higher the score. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33778150 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG071151 | Phase II trial of GM-CSF/sargramostim in Alzheimer's Disease | POTTER, HUNTINGTON | UNIVERSITY OF COLORADO DENVER | NATIONAL INSTITUTE ON AGING | 2021 to 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests3
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 | Source |
|---|---|---|
| Category Fluency | Other outcome | ConductCognition |
| Trail Making Test A | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | 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/NCT04902703
GET https://conductscience.org/api/trials/v1/NCT04902703/registered