Clinical trial: Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia (NCT00880347)

Eligibility criteria:
Inclusion Criteria:

          1. 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.

          2. 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.

          3. 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:

          1. 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.

          2. 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.

          3. 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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.


Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? Entailment