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

NCT01461174 | Completed Phase 1 DMC

• 2 other identifiers: WP1P0012011-000344-25
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Sleep deprivation; Cognitive Functions; young male

Outcome Measures

Primary Outcomes (1)

• Change in N-back

  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.

  Day 1 and Day 2 for each of the 5 Period

Secondary Outcomes (3)

• Other cognitive assessments

  Day 1 and Day 2 for each of the 5 Period

• fMRI

  Day 1 and Day 2 for each of the 5 Period

• Rest-EEG and P300 after auditory-ball paradigm Rest-EEG and P300 after auditory-ball paradigm Rest-EEG and P300 after auditory-ball paradigm

  Day 1 and Day 2 for each of the 5 Period

Study Arms (3)

Modafinil

EXPERIMENTAL

200 mg tablet, single dose

Drug: Modafinil

Donepezil

EXPERIMENTAL

5 mg tablet one per day, 15 days

Drug: Donepezil

Memantine

EXPERIMENTAL

10 mg tablet one per day, 15 days

Drug: Memantine

Interventions

Modafinil DRUG

200 mg tablet, single dose

Modafinil

Donepezil DRUG

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

Donepezil

Memantine DRUG

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

Memantine

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qualissima: lead
• European Union: collaborator

Study Sites (2)

CIC

Lille, France

Location

MEDES

Toulouse, France

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Modafinil; Donepezil; Memantine

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Amantadine; Adamantane; Bridged-Ring Compounds

Study Officials

• Christine Audebert

  CIC CPCET

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 27, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

FR (2)