Multi-parameter Diagnostic Blood Test for the Diagnosis of Alzheimer's Disease (RH-VAL)

Raman Health Technologies

Status: Completed

Conditions: Alzheimer Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02409030

RH-VAL-2013-01

Details and patient eligibility

About

The purpose of this study is to validate a diagnostic test that combines different blood markers to identify and correctly classify patients with Alzheimer's disease (AD) compared to individuals with behavioural variant frontotemporal dementia (bvFTD, patient control) versus cognitively healthy individuals (healthy control).

Full description

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.

2. 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.

3. 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.

Trial design

700 participants in 3 patient groups

Cognitively Healthy controls

Description:

The neuropsychological test assessment must confirm that there is no cognitive impairment. In the case of the cognitively healthy controls, CerebroSpinal Fluid tests performed within 24 months of inclusion will be accepted.

Alzheimer Disease

Description:

Patients with AD will be classified based on currently valid and updated diagnostic algorithms in the NIA-Alzheimer's Association of America Clinical Guidelines (2011).

Frontotemporal dementia

Description:

Inclusion criterion used will be prior diagnosis based on the diagnostic guidelines published by Dr. Rackovsky (Brain, 2011) for the behavioural variant; and those published by Prof. D. Neary (Neurology, 1998) for primary aphasia. A clinical and neuropsychological assessment is required, with the optional presence of alterations to the progranulin gene (and others) and there must be a compatible, previously performed imaging test (MRI, PET or SPECT) (predominantly frontal or frontotemporal atrophy).