Clinical trial: Impact of Controlling Vascular Risk Factors on the Progression of Alzheimer's Disease (NCT01423396)

Eligibility criteria:
Inclusion criteria

          -  Subjects aged 60 or over

          -  Subjects with Alzheimer's disease, according to the NINCDS/ADRDA diagnostic criteria
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          -  MMSE > 18

          -  Subjects with at least one VRF (whether treated or not): arterial hypertension
             (defined as SBP/DBP ≥ 140/90 mmHg in at least three different consultations or, for
             ambulatory measurements, > 130/80 mmHg with a Holter recorder or > 135/85 mmHg with a
             self-measurement device), type 2 diabetes (defined as a glycaemia value over 1.26 g/l
             (7 mmol/l) after an 8-hour fast (confirmed on two occasions), dyslipidaemia (defined
             as an LDL cholesterol level > 1.6 g/l or 1.3 or 1 g/l, depending on the patient's risk
             level)

          -  Subjects having agreed to participate in the study (provision of informed consent).

          -  Subjects accompanied by a person likely to provide information on the patient (during
             the visit or over the phone).

        Exclusion criteria

          -  Any other disease that might interfere with the evaluation of cognitive disorders.

          -  No formal education or a poor understanding of French (interfering with administration
             of the neuropsychological tests).

          -  Major physical problems likely to interfere with administration of the tests (poor
             eyesight, hearing, etc.).

          -  Non-Alzheimer's dementia (isolated vascular dementia, Lewy body dementia,
             frontotemporal dementia, etc.)

          -  Psychotropic drugs likely to modify the patient's non-stabilized cognitive state.

          -  Patients with a history of cardiovascular events can be included (randomization will
             be balanced in terms of this criterion).

          -  Participation in a therapeutic clinical trial during the study period.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 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