Donepezil Effect on Visual Attention and Training

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Université de Montréal
Sponsor:
Information provided by (Responsible Party):
Elvire Vaucher, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01738295
First received: November 20, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

The present proposal investigates the role of the cholinergic system (the neurotransmitter acetylcholine) in improving vision and visual attention. Vision results from a complex processing of particular stimuli of the visual field. Attention enhances and prolongs the neural representations of visual input in the visual cortex. It has recently been shown that attention in the visual cortex depends on cholinergic mechanisms. The action of acetylcholine in the visual cortex consists in enhancement of the responsiveness to thalamocortical inputs, depression of local neuronal connections or extrastriate feedback projections and induction of gamma synchronisation. The investigators hypothesize that these effects are associated with long-term changes in functional connectivity in the visual cortex, visual attention and visual learning (improvement of the visual capacities).

In the present proposal, the investigators will test whether the administration of donepezil (Aricept, 5mg), a drug that increases the level of acetylcholine in the brain, will enhances the perceptual-cognitive abilities of young adult subjects. Perceptual-cognitive performance will be assessed in a multiple object tracking (MOT) task in a 3D automatic virtual environment. MOT is a task where observers are asked to maintain attentional focus on a limited number of preselected subgroup of elements in a dynamic scene. Multifocal attentional mechanisms are necessary to process the information. The task will be tested five time at one week interval to test whether donepezil and training improved the task performance of the subject, i.e. lead to perceptual learning. This study could help establish an intervention procedure to improve visual performance of subjects that need it.


Condition Intervention Phase
Healthy
Drug: Donepezil administration
Drug: Placebo administration
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Donepezil Effect on Visual Attention and Perceptual Training in Healthy Young Adults

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Measure of the speed threshold, baseline [ Time Frame: week 0 ] [ Designated as safety issue: Yes ]
    The speed of the moving spheres is increased across trials until the subject is not able anymore to track and identify the indexed spheres (speed threshold). In this baseline task, the subject will not take Donepezil or placebo

  • Change from baseline of the speed threshold at 1 week [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]
    The speed of the moving spheres is increased across trials. The maximal speed for which the subject is able to track and identify the indexed spheres is the speed threshold. At this time point, the effect of Donepezil (5 mg, single dose) or placebo administration on the perceptual-cognitive performance will be assessed.

  • Change from baseline of the speed threshold at 2 weeks [ Time Frame: week 2 ] [ Designated as safety issue: Yes ]
    The speed of the moving spheres is increased across trials. The maximal speed for which the subject is able to track and identify the indexed spheres is the speed threshold. At this time point, the effect of Donepezil (5 mg, single dose) or placebo administration on the perceptual-cognitive performance will be assessed.

  • Change from baseline of the speed threshold at 3 weeks [ Time Frame: week 3 ] [ Designated as safety issue: Yes ]
    The speed of the moving spheres is increased across trials. The maximal speed for which the subject is able to track and identify the indexed spheres is the speed threshold. At this time point, the effect of Donepezil (5 mg, single dose) or placebo administration on the perceptual-cognitive performance will be assessed.

  • Change from baseline of the speed threshold at 4 weeks [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
    The speed of the moving spheres is increased across trials. The maximal speed for which the subject is able to track and identify the indexed spheres is the speed threshold. At this time point, the effect of Donepezil (5 mg, single dose) or placebo administration on the perceptual-cognitive performance will be assessed.


Estimated Enrollment: 34
Study Start Date: January 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Donepezil
Donepezil administration. In this group Donepezil (Aricept pill, 5 mg) will be orally administrated 3h before each experiment (1 week intervals)
Drug: Donepezil administration
Other Name: Aricept, Pfizer
Placebo Comparator: Lactose pill
Placebo administration. In this group, placebo (lactose pill) will be orally administrated 3h before each experiments (1 week intervals)
Drug: Placebo administration
Other Name: Lactose pill

Detailed Description:

Stages of a given perceptual-cognitive task (from Faubert and Sidebottom, Journal of Clinical Sport Psychology, 2012, 6, 85-102):

  1. a predetermined number of spheres (typically eight) are presented in a 3D dimensional virtual volumetric cube space. The spheres are typically all identical.
  2. a subset of spheres (typically four) is indexed via highlighting for a brief period of 1 s.
  3. the spheres return to their original color and start moving within the restricted 3D virtual space. During this movement, the spheres can collide and consequently suddenly change direction, and they can cross over others, thus occluding their view.
  4. the spheres stop moving after a predetermined time, and the observer has to identify the spheres that were initially indexed with halos. The subject is then given feedback on the response by having the spheres identified by revealing the appropriate indexed stimuli.

The main task starts at a given speed, and if all four spheres are not correctly identified, the next trial will be slower. If the four spheres are correctly identified, then the next trial will be faster. Trials are repeated like this following a staircase procedure, and ultimately, a speed threshold is established.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • good general health
  • 17 < body mass index < 25
  • visual acuity 6/6
  • visual stereoscopy > 50
  • standard visual field

Exclusion Criteria:

  • pregnancy or breast feeding
  • use of any drug or St John's wort
  • smoking
  • asthma
  • pulmonary obstruction
  • cardiovascular impairment
  • attention troubles
  • ocular diseases
  • epilepsy
  • lactose intolerance
  • absorption of grapefruit juice
  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: NCT01738295

Contacts
Contact: Mira Chamoun, MSc 514-343-6162 mira.chamoun@umontreal.ca
Contact: Elvire Vaucher, PhD 514-343-7537 elvire.vaucher@umontreal.ca

Locations
Canada, Quebec
School of optometry / Université de Montréal Recruiting
Montréal, Quebec, Canada, H3T 1P1
Contact: Mira Chamoun, M.Sc    (514) 343 6162    mira.chamoun@umontreal.ca   
Principal Investigator: Mira Chamoun, MSc         
Sponsors and Collaborators
Université de Montréal
Investigators
Study Director: Elvire Vaucher, PhD Université de Montréal
Study Director: Jocelyn Faubert, PhD Université de Montréal
Principal Investigator: Isabelle Legault, PhD Université de Montréal
Principal Investigator: Mira Chamoun, MSc Université de Montréal
  More Information

No publications provided

Responsible Party: Elvire Vaucher, Associate professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01738295     History of Changes
Other Study ID Numbers: 12-084-CERES
Study First Received: November 20, 2012
Last Updated: January 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by Université de Montréal:
acetylcholine
cholinergic system
visual perception
visual attention
multiple objects tracking
perceptual learning
vision training

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014