NCT00880347

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

21 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

February 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 31, 2011

Status Verified

March 1, 2011

Enrollment Period

3 years

First QC Date

April 10, 2009

Last Update Submit

March 30, 2011

Conditions

Alzheimer's DiseaseDementia

Keywords

Alzheimer's diseaseOther dementiaVascular dementiaMixed dementiaParkinson's Disease dementiaLewy bodies dementiaFrontotemporal dementiaBlood signatureDiagnosisSpliceArray (tm)Alzheimer's Disease and other non-AD dementia

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • 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)

Study Arms (3)

Alzheimer's Disease

OTHER

Group of patients clinically diagnosed with probable AD

Device: Blood sampling

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.

Device: Blood sampling

control subjects

OTHER

Group of control subjects without any clinical cognitive impairment.

Device: Blood sampling

Interventions

Blood samplingDEVICE

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,...)

Alzheimer's DiseaseNon-AD dementiacontrol subjects

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +11 more criteria

You may not qualify if:

  • 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.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Hôpital Privé Les Magnolias

Ballainvilliers, 91160, France

Location

Cabinet Médical

Bergerac, 24100, France

Location

Centre Médical

Dijon, 21000, France

Location

Cabinet Médical

La Seyne-sur-Mer, 83500, France

Location

Cabinet Médical

Le Vésinet, 78110, France

Location

Clinique Léopold Bellan

Magnanville, 78200, France

Location

Cabinet Médical

Marseille, 13001, France

Location

Centre Médical

Montpellier, 34000, France

Location

Cabinet Médical

Montpellier, 34080, France

Location

CMRR Gui de Chauliac Hospital

Montpellier, 34295, France

Location

CHU Nantes Hôpital Laennec

Nantes, 44093, France

Location

ClinOuest network

Nantes, 44300, France

Location

Cabinet Médical 2

Nice, 06000, France

Location

Cabinet Médical

Nice, 06000, France

Location

Cabinet Médical

Paris, 75016, France

Location

Centre Médical

Rambouillet, 78120, France

Location

Cabinet Médical

Rodez, 12000, France

Location

Cabinet Médical

Rueil-Malmaison, 92500, France

Location

Cabinet Médical

Saint-Brieuc, 22000, France

Location

Purpan-Casselardit Hospital - University of Toulouse

Toulouse, 31059, France

Location

CDPRV Le Capitole

Valence, 26000, France

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaDementia, VascularMixed DementiasLewy Body DiseaseFrontotemporal DementiaDisease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Olivier SOL, MD

    Exonhit

    STUDY DIRECTOR

  • Bruno Vellas, MD

    Purpan- Casselardit Hospital - Toulouse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

February 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 31, 2011

Record last verified: 2011-03

Locations

FR(21)