Clinical trial: Role of Hypoxia Ans Sleep Fragmentation in Alzheimer's Disease. and Sleep Fragmentation. (NCT02814045)

Eligibility criteria:
Inclusion Criteria:

          1. Patients diagnosed of mild probable AD according to NIA-AA criteria (MMSE>20).

          2. Informed Consent Form signed by the patient (and/or if applicable the legal
             representative if different from the responsible caregiver) and the responsible
             caregiver.

          3. The patient has a knowledgeable and reliable caregiver who will accompany the patient
             to all clinic visits during the study.

          4. Absence of visual and hearing problems that, in the investigator's judgement,
             difficult for compliance with the study procedures.

        Exclusion Criteria:

          1. Previous diagnosis of OSA.

          2. Severe Alzheimer's disease, other types of dementia or patients with mild Alzheimer's
             disease with current acetylcholinesterase inhibitors or memantine treatment.

          3. Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, chronic
             lack of sleep.

          4. Having serious comorbidities: cancer, excessive intake of alcohol (>280 gr/week),
             severe depression, severe renal or hepatic insufficiency, severe cardiac or
             respiratory failure.

          5. Currently receiving an investigational drug or device.

          6. Patient or family declining to take part.

          7. Disabling drowsiness not justifiable by any other cause.

          8. The patient has MRI evidence of hydrocephalus, stroke, a space-occupying lesion,
             cerebral infection or any clinically significant central nervous system disease other
             than AD.

          9. The patient suffers from mental retardation, organic mental disorders, or mental
             disorders due to a general medical condition (DSM-IV-TR™ criteria).

         10. The patient has an untreated vitamin B12 or folate deficiency that is considered
             clinically significant, or has clinical and laboratory evidence of untreated thyroid
             disease. Patients with vitamin B12 or folate deficiency may be enrolled in the study
             provided they have been on a supplement therapy for >3 months prior to the Screening
             Visit and are stable. Patients with thyroid disease may be enrolled in the study
             provided they are stable and euthyroid.

         11. Patient on betablockers, antidepressants, neuroleptics, hypnotics, or they have been
             removed 15 days before conducting polysomnography (PSG).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 90 Years

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? Contradiction