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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Qualissima
ClinicalTrials.gov Identifier:
NCT01461174
First received: October 17, 2011
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Healthy
Drug: Modafinil
Drug: Donepezil
Drug: Memantine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Qualissima:

Primary Outcome Measures:
  • Change in N-back [ Time Frame: Day 1 and Day 2 for each of the 5 Period ] [ Designated as safety issue: No ]
    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:
  • Other cognitive assessments [ Time Frame: Day 1 and Day 2 for each of the 5 Period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Rest-EEG and P300 after auditory-ball paradigm


Estimated Enrollment: 36
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modafinil
200 mg tablet, single dose
Drug: Modafinil
200 mg tablet, single dose
Other Name: Modafinil
Experimental: Donepezil
5 mg tablet one per day, 15 days
Drug: Donepezil
Donepezil or placebo, 5 mg tablet one per day, 15 days
Other Name: Donepezil
Experimental: Memantine
10 mg tablet one per day, 15 days
Drug: Memantine
Memantine or placebo, 10 mg tablet one per day, 15 days
Other Name: Memantine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461174

Locations
France
CIC
Lille, France
MEDES
Toulouse, France
Sponsors and Collaborators
Qualissima
European Union
Investigators
Principal Investigator: Christine Audebert CIC CPCET
  More Information

No publications provided

Responsible Party: Qualissima
ClinicalTrials.gov Identifier: NCT01461174     History of Changes
Other Study ID Numbers: WP1P001, 2011-000344-25
Study First Received: October 17, 2011
Last Updated: June 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Qualissima:
Sleep deprivation
Cognitive Functions
young male

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Memantine
Modafinil
Donepezil
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Stimulants
Neuroprotective Agents
Protective Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Nootropic Agents

ClinicalTrials.gov processed this record on July 22, 2014