Multi-parameter Diagnostic Blood Test for the Diagnosis of Alzheimer's Disease

The purpose of this study is to validate a new multi-parameter diagnostic test, on a well-characterised population based on new AD diagnostic criteria, that combines different types of markers, selected based on prior exploratory studies carried out by Raman Health Technologies.

Inclusion criteria

• Healthy controls:

• Aged between 50-80 years.
• Men and women.
• Assessment of the neuropsychological tests confirming the absence of cognitive impairment.
• Prior to participant inclusion, obtaining the results of the CerebroSpinal Fluid marker analysis (beta-amyloid, Tau protein and p-Tau) carried out in the 24 months before recruitment.
• Patients diagnosed with Alzheimer's disease (AD).

• Aged between 50-80 years.
• Men and women.
• Patients meet the clinical criteria for Alzheimer's disease:
• Prior to participant inclusion, results obtained from CerebroSpinal Fluid marker analysis (beta-amyloid, Tau protein and p-Tau) carried out in the 36 months before recruitment.
• Patients with behavioural variant frontotemporal dementia and primary progressive aphasia: -

• Aged between 50-80 years.
• Men and women.
• Patient meets the clinical criteria of behavioural variant frontotemporal dementia (bvFTD), or syndromes associated with temporal variants that affect language (primary progressive aphasia, agrammatic and semantic subgroups):

(Mild Cognitive Impairment) sub-study: Patients with mild cognitive impairment will be included

• Aged between 50-80 years.
• Men and women.
• Patient meets the clinical criteria for mild cognitive impairment:
• Clinical diagnostic criteria for mild cognitive impairment: NIA-Alzheimer's Association of America criteria, Alzheimer's Dementia, 2011
• Prior to participant inclusion, results obtained from cerebrospinal fluid marker analysis (beta-amyloid, Tau protein and p-Tau) carried out in the 12 months before recruitment.

Exclusion criteria

• Severe or acute systemic disease that could impede the participant's follow-up study: Advanced liver or kidney disease and disseminated neoplastic disease
• Addiction to alcohol or other drugs in the last two years based on Diagnostic and Statistical Manual of Mental Disorders IV criteria, except nicotine use, which is permitted
• Down's syndrome
• Moderate or severe head injury
• central nervous system infections (HIV, syphilis, borrelia, herpes simplex, suspected Creutzfeldt-Jakob disease)
• Endocrine alterations (thyroid alterations)
• Nutritional deficiency (vitamin B12, folic acid)
• Clinical history of stroke in the previous three months or neuroimaging evidence of clinically significant cardiovascular disease (e.g. strategic infarct or severe leukoencephalopathy).
• Neurological diseases (dysmyelinating disorders, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, subdural haematoma, brain tumours)
• Major psychiatric disorder (major depression or psychosis)
• Patients who do not have a clearly defined clinical diagnosis according to the study groups (inclusion/exclusion criteria)
• Disease which, in the investigator's or sponsor's judgement, may have a potentially significant influence and thus generate bias in the study markers.