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Effects of Donepezil and Memantine on Cognitive Functions After a Sleep Deprivation Challenge in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01461174
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : February 4, 2015
European Union
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Modafinil Drug: Donepezil Drug: Memantine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Effects of 15-day Donepezil and Memantine on Cognitive Functions After a 24 Hours Sleep Deprivation Challenge in Healthy Volunteers: a Double-blind, Placebo-controlled, Randomised, Cross-over Study, With Modafinil as Positive Control
Study Start Date : November 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Modafinil
200 mg tablet, single dose
Drug: Modafinil
200 mg tablet, single dose

Experimental: Donepezil
5 mg tablet one per day, 15 days
Drug: Donepezil
Donepezil or placebo, 5 mg tablet one per day, 15 days

Experimental: Memantine
10 mg tablet one per day, 15 days
Drug: Memantine
Memantine or placebo, 10 mg tablet one per day, 15 days

Primary Outcome Measures :
  1. Change in N-back [ Time Frame: Day 1 and Day 2 for each of the 5 Period ]
    The N-back test is both sensitive to SD in healthy volunteers and this test belongs to ADNI cognitive battery which is validated in Alzheimer's disease patients,considered as primary endpoint.

Secondary Outcome Measures :
  1. Other cognitive assessments [ Time Frame: Day 1 and Day 2 for each of the 5 Period ]
    CANTAB Battery, Memory Rey Auditory Verbal Learning Test (AVLT), Digit Span Test, Verbal Fluency task

  2. fMRI [ Time Frame: Day 1 and Day 2 for each of the 5 Period ]
    Resting fMRI, fMRI Memory task

  3. Rest-EEG and P300 after auditory-ball paradigm Rest-EEG and P300 after auditory-ball paradigm Rest-EEG and P300 after auditory-ball paradigm [ Time Frame: Day 1 and Day 2 for each of the 5 Period ]
    Rest-EEG and P300 after auditory-ball paradigm

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:


  1. Healthy male subjects aged between 25 and 40 years-old inclusive
  2. BMI between 18 kg/m2 to 27 kg/m2

    Health status

  3. 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.
  4. ECG (12 leads) normal (120 < PR < 200 ms; QRS < 120ms; QTcF < 450ms) and/or without clinically relevant impairments as judged by investigator.
  5. 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.
  6. No claustrophobia (fMRI)
  7. The subject has normal visual and auditory abilities

    Specific to the study

  8. Habitual good sleeping: sleeping on average 6,5 to 9 hours each night in the past month assessed by the Pittsburgh Quality Index.
  9. 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.
  10. The subject can complete the neuropsychological test battery during the training session
  11. The subject corresponds to an extravert personality according to the Eysenck Personality Inventory
  12. The subject is right-handed (Edinburgh Handedness Inventory, Imaging measurement condition).


  13. The subjects is able to read and understand the Information Form and comply with the protocol instructions and restrictions
  14. Subjects are covered by a social insurance
  15. Subjects have provided written informed consent

Exclusion Criteria:

Medical history and clinical status

  1. History or presence of psychiatric illness assessed by a psychiatric interview with the Mini-International Neuropsychiatric Interview (M.I.N.I-DSM IV).
  2. History or presence of neurologic illness or others illnesses (general medical interview)
  3. The subject has caffeine intake of greater than 5 drinks per day or excessive energy drink type intake.
  4. 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

  5. The patient, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason
  6. 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

  7. History or presence of daytime sleepiness with the Epworth scale (score > 10, pathological sleepiness).
  8. History of obstructive sleep apnea assessed by the Berlin questionnaire.
  9. History of periodic leg movements assessed by Restless Legs Syndrome questionnaire.
  10. Extreme chronotypes: score at the Horne Ostberg scale (< 31 or > 69).
  11. Jet lag > 2 hours in the last two weeks.
  12. No time-shifted work during the last month.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01461174

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Lille, France
Toulouse, France
Sponsors and Collaborators
European Union
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Principal Investigator: Christine Audebert CIC CPCET
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Responsible Party: Qualissima Identifier: NCT01461174    
Other Study ID Numbers: WP1P001
2011-000344-25 ( EudraCT Number )
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Qualissima:
Sleep deprivation
Cognitive Functions
young male
Additional relevant MeSH terms:
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Sleep Deprivation
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Central Nervous System Stimulants
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers