Effects of Donepezil and Memantine on Cognitive Functions After a Sleep Deprivation Challenge in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01461174 |
Recruitment Status :
Completed
First Posted : October 27, 2011
Last Update Posted : February 4, 2015
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: Modafinil Drug: Donepezil Drug: Memantine | Phase 1 |

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
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Drug: Modafinil
200 mg tablet, single dose |
Experimental: Donepezil
5 mg tablet one per day, 15 days
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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 |
- 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.
- 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
- fMRI [ Time Frame: Day 1 and Day 2 for each of the 5 Period ]Resting fMRI, fMRI Memory task
- 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

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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:
Demography
- Healthy male subjects aged between 25 and 40 years-old inclusive
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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)
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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
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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 Criteria:
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.
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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
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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.

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 ClinicalTrials.gov identifier (NCT number): NCT01461174
France | |
CIC | |
Lille, France | |
MEDES | |
Toulouse, France |
Principal Investigator: | Christine Audebert | CIC CPCET |
Responsible Party: | Qualissima |
ClinicalTrials.gov 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 |
Sleep deprivation Cognitive Functions young male |
Sleep Deprivation Dyssomnias Sleep Wake Disorders Nervous System Diseases Neurologic Manifestations Mental Disorders Memantine Modafinil Donepezil 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 |