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Sponsored by: |
Exonhit Therapeutics |
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Information provided by: | Exonhit Therapeutics |
ClinicalTrials.gov Identifier: | NCT00880347 |
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.
Condition | Intervention |
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Alzheimer's Disease Dementia |
Device: Blood sampling |
Study Type: | Interventional |
Study Design: | Diagnostic, Single Blind (Outcomes Assessor), Single Group Assignment |
Official Title: | 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). |
Estimated Enrollment: | 450 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Alzheimer's Disease
Group of patients clinically diagnosed with probable AD
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Device: Blood sampling
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,...)
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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.
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Device: Blood sampling
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,...)
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control subjects
Group of control subjects without any clinical cognitive impairment.
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Device: Blood sampling
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,...)
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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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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 :
Contact: Olivier Sol | +33153945245 | olivier.sol@exonhit.com |
France | |
Cabinet Médical | Recruiting |
Marseille, France, 13001 | |
CHU Nantes Hôpital Laennec | Recruiting |
Nantes, France, 44093 | |
Clinique Léopold Bellan | Recruiting |
Magnanville, France, 78200 | |
Hôpital Privé Les Magnolias | Recruiting |
Ballainvilliers, France, 91160 | |
Purpan-Casselardit Hospital - University of Toulouse | Recruiting |
Toulouse, France, 31059 | |
ClinOuest network | Completed |
Nantes, France, 44300 | |
Centre Médical | Recruiting |
Montpellier, France, 34000 | |
CDPRV Le Capitole | Recruiting |
Valence, France, 26000 | |
Centre Médical | Recruiting |
Dijon, France, 21000 | |
Centre Médical | Recruiting |
Rambouillet, France, 78120 | |
Cabinet Médical 2 | Recruiting |
Nice, France, 06000 | |
Cabinet Médical | Recruiting |
Bergerac, France, 24100 | |
Cabinet Médical | Recruiting |
Le Vesinet, France, 78110 | |
Cabinet Médical | Recruiting |
Montpellier, France, 34080 | |
Cabinet Médical | Recruiting |
Rodez, France, 12000 | |
Cabinet Médical | Recruiting |
Saint Brieuc, France, 22000 | |
Cabinet Médical | Recruiting |
Nice, France, 06000 | |
CMRR Gui de Chauliac Hospital | Recruiting |
Montpellier, France, 34295 | |
Cabinet Médical | Recruiting |
La Seyne sur Mer, France, 83500 | |
Cabinet Médical | Recruiting |
Rueil Malmaison, France, 92500 | |
Cabinet Médical | Recruiting |
Paris, France, 75016 |
Study Director: | Olivier SOL, MD | Exonhit Therapeutics |
Principal Investigator: | Bruno Vellas, MD | Purpan- Casselardit Hospital - Toulouse University |
Responsible Party: | University of Toulouse - Purpan - Casselardit Hospital ( Professor Bruno Vellas, MD ) |
Study ID Numbers: | EHTAD/002 |
Study First Received: | April 10, 2009 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00880347 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Alzheimer's disease Other dementia Vascular dementia Mixed dementia Parkinson's Disease dementia Lewy bodies dementia |
Frontotemporal dementia Blood signature Diagnosis SpliceArray (tm) Alzheimer's Disease and other non-AD dementia |
Pick Disease of the Brain Lewy Body Dementia Primary Progressive Aphasia Alzheimer Disease Central Nervous System Diseases Lewy Body Disease Brain Diseases Neurodegenerative Diseases Aphasia, Primary Progressive |
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Frontotemporal Dementia Mental Disorders Parkinson Disease Dementia, Vascular Dementia Lobar Atrophy of Brain Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |