Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia
Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia : A Prospective Study for a Blood Diagnostic Test in Alzheimer's Disease - (Protocol n° EHTAD/002).
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ballainvilliers, France, 91160
- Hôpital Privé Les Magnolias
-
Bergerac, France, 24100
- Cabinet Medical
-
Dijon, France, 21000
- Centre Médical
-
La Seyne sur Mer, France, 83500
- Cabinet Medical
-
Le Vesinet, France, 78110
- Cabinet Medical
-
Magnanville, France, 78200
- Clinique Léopold Bellan
-
Marseille, France, 13001
- Cabinet Medical
-
Montpellier, France, 34000
- Centre Médical
-
Montpellier, France, 34080
- Cabinet Medical
-
Montpellier, France, 34295
- CMRR Gui de Chauliac Hospital
-
Nantes, France, 44093
- CHU Nantes Hôpital Laennec
-
Nantes, France, 44300
- ClinOuest network
-
Nice, France, 06000
- Cabinet Medical
-
Nice, France, 06000
- Cabinet Médical 2
-
Paris, France, 75016
- Cabinet Medical
-
Rambouillet, France, 78120
- Centre Médical
-
Rodez, France, 12000
- Cabinet Medical
-
Rueil Malmaison, France, 92500
- Cabinet Medical
-
Saint Brieuc, France, 22000
- Cabinet Medical
-
Toulouse, France, 31059
- Purpan-Casselardit Hospital - University of Toulouse
-
Valence, France, 26000
- CDPRV Le Capitole
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
AD group :
- Male or female patient, aged ≥ 40 years old included at entry.
- Patients having a clinical diagnosis of probable AD according to DSM-IV TR [F00.xx] and National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
- Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations.
- Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the AD diagnosis, and that the results are compatible with AD diagnosis.
- Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD.
- Patient compliant with study procedures.
Non AD demented group :
- Male or female patient, aged ≥ 40 years old included at entry.
- Patients having a clinical diagnosis of dementia which can be one of the following :
- VaD according to NINDS-AIREN criteria or,
- LBD according to McKeith's criteria, or,
- FTD according to Neary's or Lund & Manchester criteria or,
- PDD according to DSM-IV TR criteria [F02.x] or,
- Mixed dementia which is defined in this study as patients fulfilling DSM-IV TR criteria [F02.8] for dementia with multiple aetiologies focussing on dementia of Alzheimer type with secondary occurrence of vascular dementia.
- Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations.
- Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was performed to settle the diagnosis of dementia, and that the results are compatible with the diagnosis of dementia.
- Absence of other signs or symptoms that may be better related to another type of dementia than the current dementia diagnosis.
- Patient compliant with study procedures.
Cognitive impairment-free control group :
- Male or female subject, aged ≥ 60 years old included at entry.
- Written informed consent obtained from the subject.
- Absence of spontaneously reported significant cognitive complaints from the subject at entry.
- MMSE ≥ 27 at entry.
- Subject with no impairment in daily living activities.
- Subject compliant with study procedures.
Exclusion Criteria:
AD group :
- Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of probable AD, or that may rend the initial diagnosis of probable AD doubtful at entry, according to the opinion of the investigator.
- Current or recent history of drug or alcohol abuse or dependence.
- Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting AD diagnostic criteria, and not affecting daily living activities.
- Current diagnosis of brain tumour.
- Any current pathology or medical condition, for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.
- Pregnancy.
- Patient who is not registered at "Sécurité Sociale".
- Current participation in another study using an investigational non-marketed product.
Non-AD demented group :
- Any pathology, medical condition or symptoms that may lead to reconsider the initial diagnosis of dementia the patient is suffering from, or that may rend the initial diagnosis of dementia doubtful at entry, according to the opinion of the investigator.
- Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the patient regarding memory and/or cognitive symptoms, objective memory and/or cognitive impairment at testing but not meeting the diagnostic criteria for dementia, and not affecting daily living activities.
- Current diagnosis of brain tumour.
- Any current pathology or medical condition for which blood sampling may involve a risk for the patient's health, according to the opinion of the investigator.
- Current or recent history of drug or alcohol abuse or dependence.
- Pregnancy.
- Patient who is not registered at "Sécurité Sociale".
- Current participation in another study using an investigational non-marketed product.
Cognitive impairment-free control group :
- Subject spontaneously complaining from significant cognitive impairment.
- Known family history of dementia.
- Diagnosis of any type of dementia (either AD or non-AD dementia), Mild Cognitive Impairment, or any current or past history of CNS pathology (including but not limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus, Parkinson's disease, epilepsy, multiple sclerosis,…) that may be responsible for the occurrence of dementia.
- History or current clinically significant psychiatric pathology (including but not limited to psychotic disorders, bipolar disorder, personality disorders).
- Current major depressive disorder, either treated or not, associated with clinically significant symptoms.
- Any current pathology or medical condition for which blood sampling may involve a risk for the subject's health, according to the opinion of the investigator.
- Current or recent history (within one month) of clinically significant pathology, medical condition (including hospitalization) or symptoms. However, chronic diseases or medical conditions which are considered stable are accepted, provided that they are compatible with other study selection criteria.
- Current or recent history of drug or alcohol abuse or dependence.
- Subject who is not registered at "Sécurité Sociale".
- Current participation in another study using an investigational non-marketed product.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Alzheimer's Disease
Group of patients clinically diagnosed with probable AD
|
Venous blood sampling in PaxGene tubes intended to collect blood RNA that will be then analyzed using SpliceArray (tm) technology for transcriptomic profile.
sAPPalpha levels will be also dosed.
Clinical data to be collected in parallel (medical history, concomitant treatment, MMSE,clinical examination,...)
|
|
Other: Non-AD dementia
Group of patients clinically diagnosed with one of the 5 most frequent non-AD dementia : vascular dementia, mixed dementia, frontotemporal dementia, Lewy bodies dementia, Parkinson's disease dementia.
|
Venous blood sampling in PaxGene tubes intended to collect blood RNA that will be then analyzed using SpliceArray (tm) technology for transcriptomic profile.
sAPPalpha levels will be also dosed.
Clinical data to be collected in parallel (medical history, concomitant treatment, MMSE,clinical examination,...)
|
|
Other: control subjects
Group of control subjects without any clinical cognitive impairment.
|
Venous blood sampling in PaxGene tubes intended to collect blood RNA that will be then analyzed using SpliceArray (tm) technology for transcriptomic profile.
sAPPalpha levels will be also dosed.
Clinical data to be collected in parallel (medical history, concomitant treatment, MMSE,clinical examination,...)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To define the test performance of the blood expression signatures in the intended use population of demented patients to differentiate AD patients from non-AD demented patients.
Time Frame: day 1 (cross-sectional study)
|
day 1 (cross-sectional study)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Performance of blood signatures (AD versus control, AD vs each individual type of non-AD dementia,...). Specificity of the blood signatures versus NINCDS-ADRDA criteria. Exploratory assessment of clinical parameters that may influence blood signature.
Time Frame: day1 (cross-sectional study)
|
day1 (cross-sectional study)
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Olivier SOL, MD, Exonhit
- Principal Investigator: Bruno Vellas, MD, Purpan- Casselardit Hospital - Toulouse University
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- EHTAD/002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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