Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital, Lille
Age
40–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects able to undergo a lumbar puncture;
Subjects who have a partner who will be required for driving back the subject after the lumbar punction for safety reasons (not required for control subjects);
Subjects (or the study partner for group 5) capable of and willing to comply with the protocol and to give their written informed consents after having received and understood the subject information. According to the legal protection or the mental capacities of the subject, he/she will be accompanied by him/her legally acceptable representative during this procedure;
Blood coagulation testing
Subjects registered with the French Social Security, in agreement with the French law on biomedical experimentation.
Group 1: controls
absence of cognitive complaint
absence of significant cognitive impairment: MMSE\>27
Negative ApoE4 status (ε 4-/ ε 4-) No family history of AD at first degree Group 2: asymptomatic cases with high risk to develop AD
absence of cognitive complaint
absence of significant cognitive impairment : MMSE\>27
known ApoE4 status or family history of AD at first degree Group 3: cases with isolated cognitive complaint
presence of a cognitive complaint
absence of cognitive impairment assessed by MMSE\>27 and standard neuropsychological examination (performed \< 1 year) Group 4: prodromal AD according to the 2007 criteria (Dubois et al., 2007)
progressive and significant episodic memory impairment \>6 months
And at least one of the following: medial temporal atrophy of brain MRI / low Ab42 and increased total and phosphorylated Tau protein in the CSF/ bilateral temporoparietal hypometabolism on brain FDG-PET/ positive amyloid brain PET if available
exclusion of any differential diagnoses Group 5: Mild to moderate probable AD-type dementia according to the NIA 2011 criteria
progressive and significant cognitive decline \>6 months
amnestic or any other predominant clinical presentation
exclusion of any differential diagnoses
MMSE between 15 and 26 (inclusive)
You may not be if
Subjects with dementia caused by a non-neurodegenerative disease, including patients with severe cerebrovascular risk factor load;
Associated Illnesses or conditions:
Subjects with other neurodegenerative disease such as fronto-temporal dementia (FTD), Lewy body dementia and Parkinson's disease;
Subjects with other serious neurological disorder such as brain tumour, stroke, epilepsy, hydrocephalus and any condition which contraindicates, in the investigator's judgment, entry to the study;
Subjects with demyelinating diseases of the peripheral nervous system such as Guillain-Barre Syndrome;
Subjects with known active Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV);
Subjects with clinical or significant laboratory abnormalities, in the judgment of the investigator;
Others:
Subjects with excessive alcohol intake or drug abuse, in the judgment of the investigator;
Subjects who have contraindications to perform a lumbar puncture;
Subjects who, in the opinion of the Investigator, have a risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial (for example, being impossible to contact in case of emergency).
