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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

Demography

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).

    Regulations

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
CIC
Lille, France
MEDES
Toulouse, France

Sponsors and Collaborators

Qualissima

European Union

Investigators

Principal Investigator:	Christine Audebert	CIC CPCET

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Qualissima
ClinicalTrials.gov Identifier:	NCT01461174 History of Changes
Other Study ID Numbers:	WP1P001; 2011-000344-25 ( EudraCT Number )
First Posted:	October 27, 2011
Last Update Posted:	February 4, 2015
Last Verified:	February 2015

Keywords provided by Qualissima:

Sleep deprivation; Cognitive Functions; young male

Additional relevant MeSH terms:

Sleep Deprivation; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Donepezil; Memantine; Modafinil; Armodafinil; 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; Wakefulness-Promoting Agents; Central Nervous System Stimulants; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 Enzyme Inducers