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The objective of the study is to define the performance of blood-based signatures for Alzheimer's Disease (AD) in different patients populations including AD, non-AD dementia, and non-demented controls.
The main objective of the study is to define the performance of blood-based transcriptomic signatures for AD, identified using SpliceArray tm technology, in the intended use population of patients suffering from dementia, including AD and the most common non-AD dementia (Lewy Bodies dementia, vascular dementia, fronto-temporal dementia, dementia due to Parkinson's Disease, and mixed dementia). A group of non-demented subjects will serve as a control reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alzheimer's Disease | Other | Group of patients clinically diagnosed with probable AD |
|
| Non-AD dementia | Other | 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. |
|
| control subjects | Other | Group of control subjects without any clinical cognitive impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Device | 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,...) |
| Measure | Description | 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. | day 1 (cross-sectional study) |
| Measure | Description | 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. | day1 (cross-sectional study) |
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Inclusion Criteria:
AD group :
Non AD demented group :
Cognitive impairment-free control group :
Exclusion Criteria:
AD group :
Non-AD demented group :
Cognitive impairment-free control group :
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| Name | Affiliation | Role |
|---|---|---|
| Olivier SOL, MD | Exonhit | Study Director |
| Bruno Vellas, MD | Purpan- Casselardit Hospital - Toulouse University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Les Magnolias | Ballainvilliers | 91160 | France | |||
| Cabinet Médical |
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|
| Bergerac |
| 24100 |
| France |
| Centre Médical | Dijon | 21000 | France |
| Cabinet Médical | La Seyne-sur-Mer | 83500 | France |
| Cabinet Médical | Le Vésinet | 78110 | France |
| Clinique Léopold Bellan | Magnanville | 78200 | France |
| Cabinet Médical | Marseille | 13001 | France |
| Centre Médical | Montpellier | 34000 | France |
| Cabinet Médical | Montpellier | 34080 | France |
| CMRR Gui de Chauliac Hospital | Montpellier | 34295 | France |
| CHU Nantes Hôpital Laennec | Nantes | 44093 | France |
| ClinOuest network | Nantes | 44300 | France |
| Cabinet Médical 2 | Nice | 06000 | France |
| Cabinet Médical | Nice | 06000 | France |
| Cabinet Médical | Paris | 75016 | France |
| Centre Médical | Rambouillet | 78120 | France |
| Cabinet Médical | Rodez | 12000 | France |
| Cabinet Médical | Rueil-Malmaison | 92500 | France |
| Cabinet Médical | Saint-Brieuc | 22000 | France |
| Purpan-Casselardit Hospital - University of Toulouse | Toulouse | 31059 | France |
| CDPRV Le Capitole | Valence | 26000 | France |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D015140 | Dementia, Vascular |
| D000093902 | Mixed Dementias |
| D020961 | Lewy Body Disease |
| D057180 | Frontotemporal Dementia |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D057174 | Frontotemporal Lobar Degeneration |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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