NCT02814045 · COMPLETED
Role of Hypoxia Ans Sleep Fragmentation in Alzheimer's Disease. and Sleep Fragmentation.
This is an observational study, not a drug test. Researchers follow people with mild Alzheimer's to see whether sleep fragmentation and low oxygen at night, as in sleep apnea, relate to faster memory decline. They use sleep recordings and blood and biological markers. No phase is listed, and no intervention is being tested.
You may qualify if
- Patients diagnosed of mild probable AD according to NIA-AA criteria (MMSE>20).
- Informed Consent Form signed by the patient (and/or if applicable the legal representative if different from the responsible caregiver) and the responsible caregiver.
- The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study.
- Absence of visual and hearing problems that, in the investigator's judgement, difficult for compliance with the study procedures.
You're excluded if
- Previous diagnosis of OSA.
- Severe Alzheimer's disease, other types of dementia or patients with mild Alzheimer's disease with current acetylcholinesterase inhibitors or memantine treatment.
- Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, chronic lack of sleep.
- Having serious comorbidities: cancer, excessive intake of alcohol (>280 gr/week), severe depression, severe renal or hepatic insufficiency, severe cardiac or respiratory failure.
- Currently receiving an investigational drug or device.
- Patient or family declining to take part.
- Disabling drowsiness not justifiable by any other cause.
- 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.
- The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
- 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.
- Patient on betablockers, antidepressants, neuroleptics, hypnotics, or they have been removed 15 days before conducting polysomnography (PSG).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2021-03-22