Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics

Alzheimer Disease Clinical Trial

— AWAKE  

Official title:

Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194713
• Other study ID #: AWAKE32920
• Status: Completed
• Phase: N/A
• First received: September 1, 2010
• Last updated: May 9, 2014
• Start date: March 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2014
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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 studies have shown that extended wakefulness is associated with increased production of these Abeta proteins and that sleep leads to a marked fall in their production.

Aim: The investigators aim to distinguish a similar effect of sleep disturbance on cerebrospinal fluid (CSF) Abeta levels in humans, which may point out sleep disturbance as an important factor in AD development.

Methods: a study in 26 healthy male volunteers, measuring CSF Abeta levels during a sleep deprivation night and before and after a control night with unrestricted sleep.

Expected results: The investigators expect sleep deprivation to lead to an increase in CSF Abeta levels, as compared to the levels in the control night.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Sleep Deprivation

Intervention

Behavioral:
• Sleep deprivation
subjects will undergo one night of full sleep deprivation

Locations

Country	Name	City	State
Netherlands	Clinical Research Centre Nijmegen	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Nijmegen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amyloid beta	Subjects will undergo one night of sleep deprivation before, during and after which a total of 9 CSF samples (6ml each) will be drawn through a spinal catheter. From these CSF samples Amyloid beta will be analysed.	6 timepoints during one night of sleep deprivation	No