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CompletedPhase 2

To Evaluate the Efficacy and Safety/Tolerability Profiles of G-CSF in Subjects With Mild to Moderate Alzheimer's Disease

A Open-label, No-treatment-controlled, Parallel, Pilot Phase Ⅱ Study to Evaluate the Efficacy and Safety/Tolerability Profiles of G-CSF in Subjects With Mild to Moderate Alzheimer's Disease

Asset

Filgrastim

Listed sites

1

Recruiting sites

-

Enrollment

21

actual

Study population

Alzheimer’s disease

Key I/E criteria

MMSE 12-26Study partner/caregiver required

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 ID96-0272A-ASAD-061202
NCT IDNCT03656042

Timeline

Milestones

Study start2009-03actual (month precision)
Primary completion2014-07actual (month precision)
Study completion2014-08actual (month precision)
Study first posted2018-09-04actual
Last update posted2018-09-04actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Subject with age of at lease 50 years old and no more than 85 years old

2. Subject diagnosed of Alzheimer's disease; based on the criteria of The Diagnostic and Statistical Manual of Mental Disorders (DSM)-Ⅳ for dementia and those of National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Dementia and Related Disorder Association (NINCDS - ADRDA) and within 12-months CT/MRI brain scan supporting evidences.

3. Subject with Mini-Mental Examination (MMSE) scores of 12 to 26 (inclusive).

4. Subject with Clinical Dementia Rating (CDR) score of 1 (mild) or 2 moderate).

5. Subject with Modified Hachinski Ischemic score of 4.

6. Subject with a Hamilton Psychiatric Rating Scale for Depression score of 12.

7. Female subject with child-bearing potential agrees to take reliable contraceptive method during the participation of the study (Females with no child-bearing potential have to be surgically sterilized or at least 2 years after post-menopausal).

8. Subject and subject's legally acceptable representative have given written informed consent.

9. A reliable caregiver is sufficiently familiar with the subject (as determined by the investigator) and is willing to provide accurate data

Exclusion criteria

1. Subject has underwent any of the following treatment modalities with the respective time frames:

1. Anti-epileptic agents: Within 12 weeks of the screening visit,

2. Narcotic: within 12 weeks of the screening visit,

3. Immunosuppressants: within 12 weeks of the screening visit,

4. Hypnotics: within 24 hours of the screening visit or the randomization visit,

5. Lithium: within 2 weeks of the randomization visit,

6. Succinylcholine-type muscle relaxants: within 2 weeks of the randomization visit,

7. Drugs or treatments known to cause major organ system toxicity: within 42 weeks of the randomization visit,

8. Tricyclic and tetracyclic anti-depressants: within 4 weeks of the screening visit,

9. Antiparkinsonian: Within12 weeks of the screening visit (Not including dopaminergic agent or peripheral anticholinergic agent at stable dose for at least 4 weeks of randomization visit),

10. Any medications for cognition enhancement: Within13 weeks of the screening visit(except for donepezil that has been maintained with a stable regimen for at least 12 weeks).

2. Subject is lactating, pregnant or plans to become pregnant,

3. Subject is cared primarily by nursing home,

4. Subject's AST or ALT is greater than 2 times of the upper limit or normal range.

5. Subject with diabetic history and with HbA1c > 8.5 %.

6. Subject with clinically significant medical or neurological disorders, other than AD, that may affect cognition (e.g., abnormal thyroid function tests, Vitamin B12 or folate deficiency, post-traumatic conditions Huntington's disease, Parkinson's disease, syphilis, probable/possible vascular dementia according to NINDS-AIREN criteria, active/uncontrolled seizure).

7. Subject with major psychiatric disorders.

8. Subject with spleen related disorders.

9. Subject with sickle cell disease.

10. Subject with myelodysplastic syndrome.

11. Subject with current diagnosis of acute stroke or history of acute stroke within 1 year.

12. Subject with allergy history to E. coli-derived proteins or G-CSF or donepezil.

13. Subject with cancer history and has received related therapy(ies) with in 2 years of entering this study.

14. Subject has participated other investigational study within 4 weeks of entering this study.

Endpoints (10)

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.

Coverage by outcome category

Global cognition
3
Other clinical outcomes
2
Executive function / language
1
Function / daily living
1
Behavior / neuropsychiatric
1
Neuroimaging
1
Fluid / digital biomarkers
1

Global cognition

3 endpoints
Primary/protocol endpoint

Alzheimer's Disease Assessment Scale, Cognitive subscale - Chinese version (ADAS-Cog-C)

Time frame:24 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Mini-mental State Examination (MMSE)

Time frame:Baseline, 12 weeks, 24 weeks and 48 weeks

Mini-Mental State Examination (MMSE)

ratio, descriptive

Secondary/protocol endpoint

Clinical Dementia Rating Scale (CDR)

Time frame:Baseline, 12 weeks, 24 weeks and 48 weeks

descriptive

Executive function / language

1 endpoint
Secondary/protocol endpoint

Trail making test (TMT)(Part A))

Time frame:Baseline, 12 weeks, 24 weeks and 48 weeks

event count, event

Function / daily living

1 endpoint
Secondary/protocol endpoint

Lawton and Brody Scale for Instrumental Activities of Daily Living (IADL)

Time frame:Baseline, 12 weeks, 24 weeks and 48 weeks

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Baseline, 12 weeks, 24 weeks and 48 weeks

Neuropsychiatric Inventory (NPI)

event count, event

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Change from baseline in whole brain volume determined by MRI

Time frame:Baseline, 24 weeks

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

CD34+ cell number for G-CSF treatment group

Time frame:Baseline, 12 weeks, 24 weeks and 48 weeks

change from baseline, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

AD Cooperative Study - Clinical Global Impression of change (ADCS-CGIC )

Time frame:Baseline, 12 weeks, 24 weeks and 48 weeks

descriptive

Secondary/protocol endpoint

Ten-point clock test (TPCT)

Time frame:Baseline, 12 weeks, 24 weeks and 48 weeks

descriptive

Publications (9)

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.