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NCT04902703: SESAD

Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease

Recruiting now Phase 2 Last updated 19 December 2025
What this trial tests

Phase 2 trial testing Sargramostim in Alzheimer Disease in 42 participants. Currently enrolling.

Timeline
1 June 2022
Primary endpoint
30 November 2026
30 November 2026

Quick facts

Lead sponsorUniversity of Colorado, Denver
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment42
Start date1 June 2022
Primary completion30 November 2026
Estimated completion30 November 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

Other trials of Sargramostim

Trials testing the same drug.

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other University of Colorado, Denver trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

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