Clinical trial: New Biomarker for Alzheimer's Disease Diagnostic (NCT01315639)

Eligibility criteria:
Inclusion Criteria:

        MCI group :

          -  ≥ 70 years

          -  MCI diagnosis : New criteria (Petersen, PORTET*)

               1. cognitive complaint from the patient, family, or both,

               2. report by the subject or reporter of a decline in cognitive or functional
                  performance, relative to previous abilities,

               3. cognitive disorders evidenced by clinical evaluation: impairment in memory or
                  another cognitive domain,

               4. cognitive impairment without any repercussion on daily life, even if the subject
                  reports difficulties concerning complex daily activities,

               5. no dementia

          -  Having signed an informed consent form

          -  Fluent in French

        AD group :

          -  ≥ 45 years

          -  AD diagnosis (DSM IV-TR et NINCDS-ADRDA)

          -  Mild to moderate (MMSE > 15)

          -  Having signed an informed consent form

          -  Caregiver/informant to provide information on patient

        Exclusion Criteria:

          -  Normal cognitive function

          -  Major depression (according to the DSMIV-TR or MINI or Geriatric depression Scale>
             20/30)

          -  Genetic form of AD (genetic mutation known)

          -  All other diseases that could interfere with cognitive assessment (Epilepsy,
             Parkinson's disease, schizophrenia, other dementia)

          -  Major sensory deficits that could interfere with cognitive assessment (visual and
             auditory)

          -  Diseases involving the short-term survival (advanced cancer, unstable heart disease,
             severe hepatic/respiratory/renal failure)

          -  Contraindication for MRI, for lumbar puncture (i.e. anticoagulant agents)

          -  Use of any experimental agent for the duration of the study

          -  Participation to other biomedical research that could interfere with principal
             objective of the study

          -  For MCI patient, use of IchE or memantine medication before inclusion

          -  Less than 4 years of education

          -  Illiteracy, is unable to count or to read

          -  Pregnant women

          -  Non health insurance affiliation

          -  Private subjects of freedom by legal or administrative decision

          -  Contraindication for MRI examination:

          -  Claustrophobic subject

          -  Carrying a cardiac pacemaker

          -  Presence of any ferromagnetic metallic implants or foreign bodies (carrying an
             internal electrical/magnetic device, carrying a valvular prosthesis)

          -  Carrying a ventricular valvular

        Exclusion criteria specific to the lumbar puncture:

        • Taking anticoagulant agents
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 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