NCT02409030

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 6, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2017

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2.9 years

First QC Date

March 17, 2015

Last Update Submit

March 25, 2019

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Cognitively Healthy controls

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

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

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).

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

It is estimated that a sample of 500 patients (250 with AD and 250 with FTD) and 200 controls (700 individuals in total) will be sufficient to corroborate the hypothesis that permits validation of the new diagnostic test. The sample size estimate is based on a hypothesis of non inferiority between the new test and the test used in normal clinical practice, expecting a 10% delta of the 75% validity, sensitivity and specificity indices with an alpha error of 0.05 and a beta error of 0.20.

You may qualify if:

  • Healthy controls:
  • Aged between 50-80 years.
  • Men and women.
  • Assessment of the neuropsychological tests confirming the absence of cognitive impairment.
  • Patients diagnosed with Alzheimer's disease (AD).
  • Aged between 50-80 years.
  • Men and women.
  • Patients meet the clinical criteria for Alzheimer's disease:
  • 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.
  • +2 more criteria

You may not qualify if:

  • 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)
  • Disease which, in the investigator's or sponsor's judgement, may have a potentially significant influence and thus generate bias in the study markers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

AZ Sint Jan

Bruges, 8000, Belgium

Location

UCL St Luc

Brussels, B-1200, Belgium

Location

Centre Hospitalier d'ARRAS

Arras, 62000, France

Location

Hôpital neurologique Pierre Wertheimer

Bron, 69500, France

Location

Clinique Neurologique CHRU

Lille, 59037, France

Location

Centre Mémoire paris Nord Ile de France GH Saint-Louis Lariboisière Fernand Widal

Paris, 75010, France

Location

Cognitive and Behavioral Disease Center and Alzheimer's Institute

Paris, 75013, France

Location

Hospital Marqués de Valdecilla

Santander, Cantabria, 39011, Spain

Location

Hospital Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

CITA Alzheimer

Donostia / San Sebastian, San Sebastián, 20009, Spain

Location

Hospital Sant Pau

Barcelona, 08026, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital de Valladolid

Valladolid, 47003, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

3 tubes of blood ( 30 mL of blood in total) for further analysis of their products (plasma, cells and DNA) in Alzheimer's research unit project CIEN Foundation would be extracted .

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Javier Cabello

    Raman Health Technologies, S.L.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

April 6, 2015

Study Start

January 1, 2014

Primary Completion

November 30, 2016

Study Completion

October 18, 2017

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

FR(5)BE(2)ES(9)