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CompletedPhase 1 / PHASE2Results posted

Efficacy and Safety of Filgrastim in Alzheimer's Disease

Efficacy and Safety of Filgrastim as a Pro-Cognitive Agent in Alzheimer's Disease

Lead sponsor

University of South Florida

Asset

Filgrastim

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDADDF-GCSF

NCT IDNCT01617577

Timeline

Milestones

Study start2009-06 (month precision)

Primary completion2012-02actual (month precision)

Study completion2012-02actual (month precision)

Study first posted2012-06-12estimated

Last update posted2012-12-27estimated

Results first posted2012-12-27estimated

Assets

Drug assets

Filgrastim

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•People with probable AD (by NINDS/ADRDA criteria) who are likely to be testable at the conclusion of the study period, and who do not have concurrent medical conditions or medications that might influence cognitive testing or that would increase the risk of treatment

•The participants will have a Min Mental State Examination score of between 10 and 24

•stable medical condition and stable medications for 3 months prior to screening

•study partner (spouse or caregiver) to accompany patient to all scheduled visits; able to complete baseline assessments

•physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests

Exclusion criteria

•clinically significant cardiac arrhythmia

•history of clinically significant stroke

•use of another investigational drug within 2 months of screening

•current evidence or history in the past 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder alcohol or substance abuse; residence in a skilled nursing facility (but patients in assisted living facility are acceptable)

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Global cognition

4 endpoints

Primary/protocol endpoint

Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )

Time frame:Baseline and 2wk and 4 wk after Rx;

ADAS-Cog

descriptive

Primary/protocol endpoint

Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )

Time frame:Baseline and final visit (14 wks)

ADAS-Cog

descriptive

Primary/registry result

Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )

Time frame:Baseline and 2wk and 4 wk after Rx;

ADAS-Cog

descriptive

Posted result

Group	Value (mean), units on a scale	Standard error
G-CSFADAScog Baselinen=8 Participants	22.25	2.49
ADAScog 2wk post Rxn=8 Participants	20.5	1.67
ADAScog 4wks post Rxn=8 Participants	21.5	2.507
PALmem baselinen=8 Participants	2.75	0.59
PALmem 2wk post Rxn=8 Participants	4.14	0.857
PALmem 4wk post RXn=8 Participants	5.50	1.477
PAL (tot trial adj) baselinen=8 Participants	33.87	3.02
PAL (tot trial adj) 2wk post Rxn=8 Participants	28.48	6.16
PAL(tot trial adj) 4wk post RXn=8 Participants	24.45	5.36
PlaceboADAScog Baselinen=8 Participants	22.25	2.49
ADAScog 2wk post Rxn=8 Participants	17.75	2.67
ADAScog 4wks post Rxn=8 Participants	20.125	2.14
PALmem baselinen=8 Participants	2.75	0.59
PALmem 2wk post Rxn=8 Participants	3.75	1.06
PALmem 4wk post RXn=8 Participants	4.75	0.881
PAL (tot trial adj) baselinen=8 Participants	33.87	3.02
PAL (tot trial adj) 2wk post Rxn=8 Participants	33.62	4.26
PAL(tot trial adj) 4wk post RXn=8 Participants	30.62	3.02

Primary/registry result

Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )

Time frame:Baseline and final visit (14 wks)

ADAS-Cog

descriptive

Posted result

Group	Value (mean), units on a scale	Standard error
G-CSF and PlaceboADAScog Baselinen=8 Participants	24	2.86
ADAScog 14wks post Rxn=8 Participants	20.37	2.25
PALmem baselinen=8 Participants	2.85	0.67
PALmem 14wk post RXn=8 Participants	5.17	1.41
PAL (tot trials adj) baselinen=8 Participants	33.88	3.003
PAL (tot trials adj) 14wk post RXn=8 Participants	30.	3.65

p0.36Wilcoxon (Mann-Whitney)

ADAScog scores at baseline vs final visit (wk 14); null hypothesis is there is no difference between scores

p0.058Wilcoxon (Mann-Whitney)

PAL(mem) at baseline and 14 wk (final visit): null hypothesis is thereis no difference in score

p0.034Wilcoxon (Mann-Whitney)

PALtot trials adj at baseline vs 14wk (final visit)

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Sanchez-Ramos J, Song S, Sava V, Catlow B, Lin X, Mori T, Cao C, Arendash GW. Granulocyte colony stimulating factor decreases brain amyloid burden and reverses cognitive impairment in Alzheimer's mice. Neuroscience. 2009 Sep 29;163(1):55-72. doi: 10.1016/j.neuroscience.2009.05.071. Epub 2009 Jun 14.
PMID19500657via BACKGROUND

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.