Subjects in the treatment group will receive Filgrastim (75mcg/0.3ml, NEUPOGEN®), 10 mic/kg/day, by sc, for 5 continuous days for the first week, rest for 11 weeks. Filgrastim will be given 12-weekly ( 12 weeks/cycle ) for 2 cycles.

No-treatment group is used to control evaluation bias and potential time effect.

Alzheimer's Disease

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:
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
Non-treatment

Filgrastim (75mcg/0.3ml)

Chang Gung Memorial Hospital

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

The total score ranges from 0 to 75 and the higher the score, the greater the impairment. ADAS-Cog-C has 11 items and each has its score range:
Word Recall Task: maximum score = 10 Naming Task: maximum score = 5 Commands: maximum score = 5 Constructional Praxis: maximum score = 5 Ideational Praxis: maximum score = 5 Orientation: maximum score = 8 Word Recognition: maximum score = 12 Remembering Test Instructions: maximum score = 5 Spoken Language Ability: maximum score = 5 Word-Finding Difficulty: maximum score = 5 Comprehension: maximum score = 5 We measure the change from baseline in ADAS-Cog at 24-week visit.

The Mini-Mental State Examination (MMSE) is a 30-point questionnaire.
The score ranges are as follows:
Orientation to time 5 Orientation to place 5 Registration 3 Attention and calculation 5 Recall 3 Language 2 Repetition 1 Complex commands 5

The Clinical Dementia Rating Scale is a 5-point scale used to characterize six domains of cognitive and functional performance to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care.
In each domain, the severity degree of each symptom correspond to different rating score from 0(none) to 3(severe). The total score ranges from 0 to 18

Interviewer scores the severity as follow:
Not impaired / not present
Borderline impairment
Mild impairment
Moderate impairment
Marked impairment
Severe impairment
very severe

The test measures eight realms of function through self report, which attempt to assess everyday functional competence in the elderly. Each item is rated either dichotomously (0 = less able, 1 = more able) or trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men.

The NPI originally examined 12 sub-domains of behavioral functioning Each domain is scored for frequency, severity and associated caregiver distress.
Frequency:Rarely,Sometimes,Often,Very often Severity:Mild,Moderate,Severe Caregiver Distress:0(not at all),1(minimally),2(mildly),3(moderately),4(severely),5(very severely or extremely). Total score will range from Less than 20(symptoms are mild),20-50(symptoms are moderate) to 50 or over(symptoms are severe)

One point is given for each of the following numbers that falls in its proper eighth of the circle relative to the number 12: 1.2, 4,5,7, 8, 10, and 11. One point is given each to a short hand pointing at the number eleven, and a long hand pointing at the number two. The total score ranges from 0 to 10.

G-CSF may promote mobilizing bone marrow CD34+ stem cells. We will compare the CD34+ cell number between treatment and control group at the baseline and follow up sequential change in the treatment group.

The Trail Making Test is a neuropsychological test of visual attention and task switching. Results for Trail making test A (Part A) is reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average time is 29 seconds. If the subject uses more than 78 seconds, cognitive deficient is impressed.

Change from baseline in whole brain volume determined by MRI. MRI examination will be performed within 7 days before the start at the start of first cycle (Visit 2) and week-24 visit (Visit 10), to compare the change of whole brain volume.

Individual participant data sets including IPD that underlie results in a publication have not yet decided to be shared under the consideration of patient privacy.

moderate or severe HIE among term and late preterm newborn

Ischemic-Hypoxic Encephalopathy

Chu Amiens

Chu Besancon

Chu Bordeaux

Chu Brest

CHU CAEN

CHU Clermond-Ferrand

Chi Creteil

Chu Dijon

CHU FORT de France

Chu Grenoble

Chru Lille

Chu Limoges

Chu Marseille

CHU Montpellier

Chu La Miletrie

Chu Reims

Chu Rouen

CHU St Denis

CHU St Pierre

Chu Strasbourg

Chu Toulouse

Chu Tours

Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy With Hypothermia Treatment

Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy in the Era of Neuroprotective Treatment With Hypothermia

A combined criterion which includes:
Death between birth and 3 years of age
Neurodevelopmental disabilities in survivors, defined as :
o Severe disabilities
Intellectual impairment with a mental score >2SD below the mean or <70 (ASQ)
Or Cerebral palsy with a Gross Motor Function level of 3-5 according to the GMFCS
Or bilateral blindness (vision <20/200 acuity)
Or deafness requiring amplification (>60dB)and/
Or a persistent disorder defined as recurrent seizures after discharge from neonatal intensive care requiring anti-convulsion therapy at the examination time point
o Moderate disabilities
Intellectual impairment with a mental score >1SD below the mean or 70 to 84 (ASQ)
Cerebral palsy with a Gross Motor Function level of 1 or 2 according to the GMFCS
Or hearing impairment requiring no amplification

The biologist will evaluate the relevance of specific new biomarkers :
Protein levels (IL-6, MMP-9, TIMP-1, Albumine modified by hypoxia, troponine I) unites will be determined using an ELISA
the measurement of acylcarnitins and amino acids by tandem liquid phase chromatography coupled with mass spectroscopy.
The analyses will be blinded and centralized to Reims University laboratory

To analyze the predictive value of clinical investigations during the first weeks of life and treatments, including cooling:
for normal outcomes (absence of death, any disability, any epilepsy or any need for physiotherapy, orthophonist or psychologist or other measures of reeducation), moderate or severe neurodevelopmental disabilities, and death
At 18 months and 3 years of age
In this part, we will assess the ability of a normal developmental assessment at 18 months to predict survival free of disability or retardation at 3 years. This information will be useful in the future to define different strategies of follow up according to the assessment at 18 months of age.

The third secondary objective is analyzed thanks to :
number of patients with method of cooling : Criticool, tecotherm, craft, other
duration of cooling in hours
number of severe or modere HIE according to the Sarnat classification
time to initiate cooling in minutes

Number and percentage of :
Maternal pyrexia,
a persistent occipito-posterior position,
an acute intrapartum event (hemorrhage, maternal convulsions, rupture of uterus, snapped cord, and birth of baby before arrival at obstetric facility),
an instrumental vaginal delivery
an emergency caesarean section

brain ischemia/albumine

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

Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy With Hypothermia Treatment

Carotid Atherosclerosis Regression at Magnetic Resonance Assessment.

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