Status:
COMPLETED
Effects of Donepezil and Memantine on Cognitive Functions After a Sleep Deprivation Challenge in Healthy Volunteers
Lead Sponsor:
Qualissima
Collaborating Sponsors:
European Union
Conditions:
Healthy
Eligibility:
MALE
25-40 years
Phase:
PHASE1
Brief Summary
The aim of this study is to assess the utility of sleep deprivation as a potential model for prediction of clinical efficacy using a combination of cognitive physiological endpoints.
Detailed Description
BACKGROUND: With the inherent difficulty of detecting significant improvements in cognitive performance in normal healthy subjects, it is presently incredibly hard to predict and select efficacious a...
Eligibility Criteria
Inclusion
- Demography
- Healthy male subjects aged between 25 and 40 years-old inclusive
- BMI between 18 kg/m2 to 27 kg/m2
- Health status
- The subjects is in good health on the basis of the medical interview (medical history, symptoms) and the physical examination, vital signs and the results of blood chemistry and hematology.
- ECG (12 leads) normal (120 \< PR \< 200 ms; QRS \< 120ms; QTcF \< 450ms) and/or without clinically relevant impairments as judged by investigator.
- The subject does not smoke or smokes a maximum of 5 cigarettes per day and is able to stop during the days of the study.
- No claustrophobia (fMRI)
- The subject has normal visual and auditory abilities
- Specific to the study
- Habitual good sleeping: sleeping on average 6,5 to 9 hours each night in the past month assessed by the Pittsburgh Quality Index.
- Regular sleeping hours whereby they sleep no later than 1 am and rise before 9 am in the past month assessed by the Pittsburgh Quality Index.
- The subject can complete the neuropsychological test battery during the training session
- The subject corresponds to an extravert personality according to the Eysenck Personality Inventory
- The subject is right-handed (Edinburgh Handedness Inventory, Imaging measurement condition).
- Regulations
- The subjects is able to read and understand the Information Form and comply with the protocol instructions and restrictions
- Subjects are covered by a social insurance
- Subjects have provided written informed consent
Exclusion
- Medical history and clinical status
- History or presence of psychiatric illness assessed by a psychiatric interview with the Mini-International Neuropsychiatric Interview (M.I.N.I-DSM IV).
- History or presence of neurologic illness or others illnesses (general medical interview)
- The subject has caffeine intake of greater than 5 drinks per day or excessive energy drink type intake.
- The subject has an orthostatic blood pressure reduction \> 20 mm Hg, based on a difference of systolic blood pressure between supine and after standing for 3 minutes.
- General conditions
- The patient, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason
- The subject participates to another clinical trial or is still being within a washout period of a previous clinical trial, or subjects who received more than 4500 euros in the previous 12 months.
- Specific to the study
- History or presence of daytime sleepiness with the Epworth scale (score \> 10, pathological sleepiness).
- History of obstructive sleep apnea assessed by the Berlin questionnaire.
- History of periodic leg movements assessed by Restless Legs Syndrome questionnaire.
- Extreme chronotypes: score at the Horne Ostberg scale (\< 31 or \> 69).
- Jet lag \> 2 hours in the last two weeks.
- No time-shifted work during the last month.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01461174
Start Date
November 1 2011
End Date
November 1 2014
Last Update
February 4 2015
Active Locations (2)
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1
CIC
Lille, France
2
MEDES
Toulouse, France