New Biomarker for Alzheimer's Disease Diagnostic (BALTAZAR)
Alzheimer's Disease, Mild Cognitive Impairment
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Dementia, Cognitive impairment, Memory impairment, Mild Cognitive Impairment, Cerebrospinal fluid, Plasma, Biomarker, Longitudinal, Abeta peptide amyloid, saPP alpha, Oculomotor impairment
Eligibility Criteria
Inclusion Criteria:
MCI group :
- ≥ 70 years
MCI diagnosis : New criteria (Petersen, PORTET*)
- cognitive complaint from the patient, family, or both,
- report by the subject or reporter of a decline in cognitive or functional performance, relative to previous abilities,
- cognitive disorders evidenced by clinical evaluation: impairment in memory or another cognitive domain,
- cognitive impairment without any repercussion on daily life, even if the subject reports difficulties concerning complex daily activities,
- no dementia
- Having signed an informed consent form
- Fluent in French
AD group :
- ≥ 45 years
- AD diagnosis (DSM IV-TR et NINCDS-ADRDA)
- Mild to moderate (MMSE > 15)
- Having signed an informed consent form
- Caregiver/informant to provide information on patient
Exclusion Criteria:
- Normal cognitive function
- Major depression (according to the DSMIV-TR or MINI or Geriatric depression Scale> 20/30)
- Genetic form of AD (genetic mutation known)
- All other diseases that could interfere with cognitive assessment (Epilepsy, Parkinson's disease, schizophrenia, other dementia)
- Major sensory deficits that could interfere with cognitive assessment (visual and auditory)
- Diseases involving the short-term survival (advanced cancer, unstable heart disease, severe hepatic/respiratory/renal failure)
- Contraindication for MRI, for lumbar puncture (i.e. anticoagulant agents)
- Use of any experimental agent for the duration of the study
- Participation to other biomedical research that could interfere with principal objective of the study
- For MCI patient, use of IchE or memantine medication before inclusion
- Less than 4 years of education
- Illiteracy, is unable to count or to read
- Pregnant women
- Non health insurance affiliation
- Private subjects of freedom by legal or administrative decision
- Contraindication for MRI examination:
- Claustrophobic subject
- Carrying a cardiac pacemaker
- Presence of any ferromagnetic metallic implants or foreign bodies (carrying an internal electrical/magnetic device, carrying a valvular prosthesis)
- Carrying a ventricular valvular
Exclusion criteria specific to the lumbar puncture:
• Taking anticoagulant agents
Sites / Locations
- APHP, Hôpital Broca
Arms of the Study
Arm 1
Other
biomarkers, MRI and CSF
Longitudinal multicenter study including 1300 subjects with amnestic impairment (MCI, n=650 and AD, n=650) derived from the main French national Memory Resources and Research Centers. Participants will undergo at baseline and every 6 months a neurological examination, a neuropsychological assessment (and an oculomotor examination for those included from Broca Hospital). Alzheimer disease biomarkers' measurements will be performed at inclusion and at the end of the study (or the conversion).