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NCT04902703: SESAD
Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease
Phase 2 trial testing Sargramostim in Alzheimer Disease in 42 participants. Currently enrolling.
30 November 2026
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 1 June 2022 |
| Primary completion | 30 November 2026 |
| Estimated completion | 30 November 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sargramostim (SARGRAMOSTIM) — full drug profile →
- Saline - placebo comparator — full drug profile →
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
Sponsor
University of Colorado, Denver
Who can join
Adults 60 to 85, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A medicine that is FDA-approved for bone marrow stimulation (called sargramostim) will be tested for its safety and efficacy in individuals with mild-to-moderate Alzheimer's disease over a six month treatment period.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Alzheimer's disease drug development pipeline: 2022.
Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295 -
Alzheimer's disease drug development pipeline: 2023.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385 -
Alzheimer's disease drug development pipeline: 2024.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2024 · cited 209× · PMID 38659717 · DOI 10.1002/trc2.12465 -
The Link between Oxidative Stress, Mitochondrial Dysfunction and Neuroinflammation in the Pathophysiology of Alzheimer's Disease: Therapeutic Implications and Future Perspectives.
Jurcău MC, Andronie-Cioara FL, Jurcău A, Marcu F, et al · · 2022 · cited 119× · PMID 36358538 · DOI 10.3390/antiox11112167 -
Molecular Mechanisms of Neuroinflammation in Aging and Alzheimer's Disease Progression.
Andronie-Cioara FL, Ardelean AI, Nistor-Cseppento CD, Jurcau A, et al · · 2023 · cited 109× · PMID 36768235 · DOI 10.3390/ijms24031869 -
The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de-risk trial programmes of novel agents.
Correll CU, Solmi M, Cortese S, Fava M, et al · · 2023 · cited 90× · PMID 36640403 · DOI 10.1002/wps.21056 -
Alzheimer's Disease: Novel Targets and Investigational Drugs for Disease Modification.
Cummings JL, Osse AML, Kinney JW. · · 2023 · cited 75× · PMID 37728864 · DOI 10.1007/s40265-023-01938-w -
Alzheimer's disease and neuroinflammation: will new drugs in clinical trials pave the way to a multi-target therapy?
Melchiorri D, Merlo S, Micallef B, Borg JJ, et al · · 2023 · cited 38× · PMID 37332353 · DOI 10.3389/fphar.2023.1196413
Verify or expand the search:
- PubMed search for NCT04902703
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04902703 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 19 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04902703.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing