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

Alzheimer Disease Clinical Trial

— RH-VAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409030
• Other study ID #: RH-VAL-2013-01
• Status: Completed
• Start date: January 2014
• Est. completion date: October 18, 2017

Study information

• Verified date: March 2019
• Source: Raman Health Technologies, S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: October 18, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Locations

Country	Name	City	State
Belgium	AZ Sint Jan	Brugge
Belgium	UCL St Luc	Brussel
France	Centre Hospitalier d'ARRAS	Arras
France	Hôpital neurologique Pierre Wertheimer	Bron
France	Clinique Neurologique CHRU	Lille
France	Centre Mémoire paris Nord Ile de France GH Saint-Louis Lariboisière Fernand Widal	Paris
France	Cognitive and Behavioral Disease Center and Alzheimer's Institute	Paris
Spain	Hospital Clinic	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	CITA Alzheimer	Donostia / San Sebastián	San Sebastián
Spain	Hospital Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Raman Health Technologies, S.L.

Countries where clinical trial is conducted

Belgium,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood markers	Multi-parameter determination: Raman laser and infrared spectroscopic markers, Metabolite-based markers (A02, A16, A22 ST01 F20 M30), Protein markers (A, A-T, B, PRO-B, C, C1, C2, PROGRANULIN), Biochemical markers (OXIDATIVE STRESS MARKERS, CTAN, ROUTINE BIOCHEMICAL MARKERS (GLUCOSE, TRIGLYCERIDES) and Genetic markers (ApoE, ApoC).	Up to 12 months