Status:
COMPLETED
Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics
Lead Sponsor:
University Medical Center Nijmegen
Conditions:
Alzheimer Disease
Eligibility:
MALE
40-60 years
Phase:
NA
Brief Summary
Introduction: Alzheimer's disease (AD) is characterized by neurodegeneration of the brain in the form of neurofibrillary tangles and plaques containing the amyloid-beta protein (Abeta). Recent animal ...
Eligibility Criteria
Inclusion
- Written informed consent
- Age 40-60 years
- Male
- Subject is in good health as established by medical history, physical examination, ECG and laboratory examination
- Laboratory parameters (as described on in section 3.7 screening) should be within the normal ranges as applicable in RUNMC, Nijmegen, or clinically acceptable to the investigator
- Normal sleep behaviour, Pittsburg Sleep Quality index score ≤5
- MMSE 28 or higher
- Medication free
Exclusion
- Presence of blood coagulopathy, established by medical history
- Allergy to local anesthetic agents
- Contra-indication for spinal catheter placement: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine
- Subjects who are currently participating in another study or have participated in a clinical study within 30 days, based on their own report about participation history
- Subjects with a history of drug or alcohol abuse
- Subjects who are part of the study staff personnel or family members of the study staff personnel
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01194713
Start Date
March 1 2011
End Date
September 1 2013
Last Update
May 13 2014
Active Locations (1)
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1
Clinical Research Centre Nijmegen
Nijmegen, Gelderland, Netherlands, 6500HB