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

NCT03656042 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-09-04

No results posted yet for this study

Summary

With the enrichment of living environment and the progress of medicine, the scale of aging population has increased in many countries of the world. Alzheimer's disease (AD), the leading cause of dementia, counts for approximately 60% to 70% in dementia in aged population. AD is a well-known neurodegenerative disease and characterized by the formation of neurofibrillary tangles and deposition of amyloid in the brain. It also affects more than 12 million patients worldwide and puts a tremendous burden on family caregivers and causes high nursing home costs for society. So far, the mechanisms of AD have not been elucidated and currently no curable treatment exists. Thus, clinical trials concerning the treatment of AD are in urgent expectation.

Granulocyte-colony stimulating factor (G-CSF) is a growth factor that presents in human body in small quantity and is known to promote the blood cell proliferation and differentiation. Previous studies showed injection of G-CSF could help release hematopoietic stem cell (HSCs) from bone marrow to the peripheral blood, and then migrate to repair damaged areas, e.g. heart tissue and ischemia brain tissue. We have found that G-CSF triggering release of stem cells from bone marrow shows the potential as an effective reagent for treatment of AD by using two AD mouse models. The one was generated by injecting the brains of normal mice with amyloid and another was by using a strain of transgenic mice which naturally exhibit Alzheimer's disease-like neuronal apoptosis and memory loss. Subcutaneous administration of G-CSF into mice significantly rescued their cognitive/memory functions.

G-CSF has already been widely used in clinical practice, for example, neutropenia caused by chemotherapy in cancer and bone marrow transplantation. The new finding shows G-CSF can release HSCs from bone marrow and these cells not only can pass through the blood-brain barrier but can selectively migrate to the region of damaged brain to improve neurological recovery. Thus, we conduct this clinical trial to investigate the potential effect of G-CSF for the cognitive function of AD patients. If successful, G-CSF could open up a new window for AD treatment which is less invasive and more effective than the current therapies.

Conditions

Interventions

DRUG

Filgrastim (75mcg/0.3ml)

Subjects who meet all eligible requirements for entry into the study will be randomized into one of the two treatment groups in 1:1 ratio as shown below: 1. 10 microgram/kg/day, by sc, for 5 continuous days for the first week, rest for 11 weeks; repeat dosing regimen every 12-weekly (12 weeks / cycle) for 2 cycles 2. Non-treatment

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Wen-Chuin Hsu, M.S. · Chang Gung Memorial Hospital, Linkou medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03656042 on ClinicalTrials.gov