Donepezil Effect on Visual Attention and Training

NCT01738295 | Completed DMC

• 1 other identifier: 12-084-CERES
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

acetylcholine; cholinergic system; visual perception; visual attention; multiple objects tracking; perceptual learning; vision training

Outcome Measures

Primary Outcomes (5)

• Measure of the speed threshold, baseline

  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

  week 0

• Change from baseline of the speed threshold at 1 week

  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.

  week 1

• Change from baseline of the speed threshold at 2 weeks

  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.

  week 2

• Change from baseline of the speed threshold at 3 weeks

  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.

  week 3

• Change from baseline of the speed threshold at 4 weeks

  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.

  week 4

Study Arms (2)

Donepezil

ACTIVE COMPARATOR

Donepezil administration. In this group Donepezil (Aricept pill, 5 mg) will be orally administrated 3h before each experiment (1 week intervals)

Drug: Donepezil administration

Lactose pill

PLACEBO COMPARATOR

Placebo administration. In this group, placebo (lactose pill) will be orally administrated 3h before each experiments (1 week intervals)

Drug: Placebo administration

Interventions

Donepezil administration DRUG

Also known as: Aricept, Pfizer

Donepezil

Placebo administration DRUG

Also known as: Lactose pill

Lactose pill

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

School of optometry / Université de Montréal

Montreal, Quebec, H3T 1P1, Canada

Location

MeSH Terms

Interventions

Donepezil; Lactose

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Elvire Vaucher, PhD

  Université de Montréal

  STUDY DIRECTOR

• Jocelyn Faubert, PhD

  Université de Montréal

  STUDY DIRECTOR

• Isabelle Legault, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Mira Chamoun, MSc

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 30, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: June 5, 2017

Record last verified: 2015-08

Locations

CA (1)