Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease

Exclusion Criteria

• •FOR ALL
• •Any of the following medications within 1 week prior to inclusion:
• •* Anti-inflammatory
• •* Anti-neoplastic
• •* Immunosuppressives
• •* Systemic corticosteroids
• •Vaccination with live vaccines within 3 weeks and/or with inactivated vaccines within 2 weeks prior to inclusion
• •On-going viral or bacterial infection requiring at least symptomatic treatment, or antibiotics, or associated with fever or pain.
• •Any psychiatric condition, which in the opinion of the investigator might preclude participation.
• •Any lab abnormality, which in the opinion of the investigator might preclude participation.
• •Pregnant woman or lactating or planning pregnancy during the course of the study (Includes a negative urine pregnancy test or to be of non-child bearing potential).
• •Participant who does not wish to be informed of any clinically relevant abnormalities (as determined by the investigator at that site) identified during the course of the study (For France only).
• •PARKINSON'S DISEASE GROUP
• •Idiopathic PD patients:
• •Family history of PD.
• •Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
• •Currently taking neuroleptics or has taken neuroleptics within 6 months of baseline.
• •Under guardianship or curatorship.
• •PD patients with mutation in Parkin, LRRK2 or GBA gene:
• •Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
• •Currently taking neuroleptics or has taken neuroleptics within 6 months of baseline.
• •Under guardianship or curatorship.
• •Subjects at risk of PD:
• •Clinically significant abnormal neurological examination (in the opinion of the investigator).
• •A clinical diagnosis of PD as determined by the investigator.
• •Currently taking neuroleptics or has taken neuroleptics within 6 months of baseline.
• •Under guardianship or curatorship.
• •PD Healthy control subjects:
• •A recent or ongoing, uncontrolled, clinically significant medical condition within 3 months of screening (such as, but not limited to, diabetes, hypertension, thyroid or endocrine disease congestive heart failure, angina, cardiac or gastrointestinal disease)
• •Current or active clinically significant neurological disorder (in the opinion of the investigator).
• •First-degree relative with idiopathic PD (parent, sibling, child).
• •Received any drugs that might interfere in the opinion of the investigator with neurological and cognitive assessments: for example neuroleptics, benzodiazepine or antidepressant.
• •Under guardianship or curatorship.
• •ALZHEIMER'S DISEASE GROUP
• •Prodromal AD patients:
• •Rosen-modified Hachinski Ischemia Score \> 4 at screening (ie, evidence of vascular dementia).
• •Known history of stroke or evidence from MRI scan that is clinically important in the investigator's opinion.
• •Evidence of a clinically relevant neurological disorder other than the disease being studied (ie, probable AD), including but not limited to: vascular dementia, parkinsonism, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, neurosyphilis, dementia with Lewy bodies, other types of dementia, mental retardation, hypoxic cerebral damage, cognitive impairment due to other disorders, or head trauma with loss of consciousness that led to persistent cognitive deficits.
• •The subject has evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria,
• •Previous MRI scan showing evidence of a neurological disorder other than probable AD or \> 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), a single area of superficial siderosis, evidence of a prior macrohemorrhage, 3 lacunar infarcts, any cortical infarct over 5 mm, or any other clinically significant finding (eg, brain tumor).
• •A recent or ongoing, uncontrolled, clinically significant medical condition within 3 months of the screening (such as, but not limited to, diabetes, hypertension, thyroid or endocrine disease congestive heart failure, angina, cardiac or gastrointestinal disease)
• •The subject has:
• •1. a history of clinically significant vitamin B12 or folate deficiency in the 6 months immediately before Screening, or
• •2. vitamin B12 or folate deficiency in addition to increased serum homocysteine or methylmalonic acid levels at screening.
• •Contraindications for MRI scan (pacemaker, implanted cardioverter-defibrillator, neurostimulation system, cochlear implant, metallic foreign body (metal sliver) in the eye, metallic prosthesis, cerebral aneurysm clip, ventriculoperitoneal neurosurgical bypass valve, fixed dental prosthesis, known claustrophobia).
• •Contraindications for lumbar puncture: current treatment with anticoagulants (e.g., coumadin, heparin) or double antiaggregant therapy.
• •Preclinical AD patients (asymptomatic at risk of AD):
• •Rosen-modified Hachinski Ischemia Score \> 4 at screening (ie, evidence of vascular dementia).
• •Known history of stroke or evidence from MRI scan that is clinically important in the investigator's opinion.
• •Evidence of a clinically relevant neurological disorder other than the disease being studied (ie, probable AD), including but not limited to: vascular dementia, parkinsonism, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, progressive supranuclear palsy, neurosyphilis, dementia with Lewy bodies, other types of dementia, mental retardation, hypoxic cerebral damage, cognitive impairment due to other disorders, or head trauma with loss of consciousness that led to persistent cognitive deficits.
• •The subject has evidence of a clinically relevant or unstable psychiatric disorder, based on DSM-IV-TR criteria,
• •Previous MRI scan showing evidence of a neurological disorder other than probable AD or \> 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), a single area of superficial siderosis, evidence of a prior macrohemorrhage, 3 lacunar infarcts, any cortical infarct over 5 mm, or any other clinically significant finding (eg, brain tumor).
• •The subject has:
• •1. a history of clinically significant vitamin B12 or folate deficiency in the 6 months immediately before Screening, or
• •2. vitamin B12 or folate deficiency in addition to increased serum homocysteine or methylmalonic acid levels at screening.
• •Contraindications for MRI scan (pacemaker, implanted cardioverter-defibrillator, neurostimulation system, cochlear implant, metallic foreign body (metal sliver) in the eye, metallic prosthesis, cerebral aneurysm clip, ventriculoperitoneal neurosurgical bypass valve, fixed dental prosthesis, known claustrophobia).
• •Contraindications for lumbar puncture: current treatment with anticoagulants (e.g., coumadin, heparin) or double antiaggregant therapy.
• •Under guardianship or curatorship.
• •AD Healthy control subjects:
• •A recent or ongoing, uncontrolled, clinically significant medical condition within 3 months of screening (such as, but not limited to, diabetes, hypertension, thyroid or endocrine disease congestive heart failure, angina, cardiac or gastrointestinal disease)
• •Current or active clinically significant neurological disorder (in the opinion of the investigator).
• •Received any drugs that might interfere in the opinion of the investigator with neurological and cognitive assessments: for example neuroleptics, benzodiazepine or antidepressant.
• •Contraindications for MRI scan (pacemaker, implanted cardioverter-defibrillator, neurostimulation system, cochlear implant, metallic foreign body (metal sliver) in the eye, metallic prosthesis, cerebral aneurysm clip, ventriculoperitoneal neurosurgical bypass valve, fixed dental prosthesis, known claustrophobia).
• •Contraindications for lumbar puncture: current treatment with anticoagulants (e.g., coumadin, heparin) or double antiaggregant therapy, clinically significant coagulopathy or thrombocytopenia.
• •Under guardianship or curatorship.