Alzheimer DiseaseRH-VALNCT02409030
Multi-parameter Diagnostic Blood Test for the Diagnosis of Alzheimer's Disease
An observational study of Alzheimer Disease, run by Raman Health Technologies, S.L. at 16 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 700 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Jan 2014to 18 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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)
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- 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 locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Spain9 sites
Hospital Sant Pau
Barcelona, 08026
Hospital Clinic
Barcelona, 08036
CITA Alzheimer
Donostia / San Sebastian, San Sebastián, 20009
Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Gregorio Marañón
Madrid, 28007
Hospital Ramón y Cajal
Madrid, 28034
Hospital La Paz
Madrid, 28046
Hospital Marqués de Valdecilla
Santander, Cantabria, 39011
Hospital de Valladolid
Valladolid, 47003
France5 sites
Centre Hospitalier d'ARRAS
Arras, 62000
Hôpital neurologique Pierre Wertheimer
Bron, 69500
Clinique Neurologique CHRU
Lille, 59037
Centre Mémoire paris Nord Ile de France GH Saint-Louis Lariboisière Fernand Widal
Paris, 75010
Cognitive and Behavioral Disease Center and Alzheimer's Institute
Paris, 75013
About this study
Official title: Validation Trial for a Multi-parameter Diagnostic Blood Test for the Diagnosis of Alzheimer's Disease
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).
Read the detailed 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.
- Conditions
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startJan 2014
- Primary completion30 Nov 2016
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raman Health Technologies, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Cabello, Study director, Raman Health Technologies, S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409030
- Sponsor's protocol ID
- RH-VAL-2013-01
- Acronym
- RH-VAL
- Status last verified
- Mar 2019
- First submitted
- 17 Mar 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Trial for a Multi-parameter Diagnostic Blood Test for the Diagnosis of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02409030
- Acronym / sponsor ID
- RH-VAL / RH-VAL-2013-01
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Raman Health Technologies, S.L.Industry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- Healthy controls:
- Patients diagnosed with Alzheimer's disease (AD).
- Patients with behavioural variant frontotemporal dementia and primary progressive aphasia: -
- (Mild Cognitive Impairment) sub-study: Patients with mild cognitive impairment will be included
- Aged between 50-80 years.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood markers
Time frame: Up to 12 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Cabello study director
Raman Health Technologies, S.L.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Raman Health Technologies, S.L. at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Spain, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood markers (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.