HealthyNCT01738295
Donepezil Effect on Visual Attention and Training
A study testing Donepezil administration in people with Healthy, run by Université de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Donepezil administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good general health
- 17 < body mass index < 25
- visual acuity 6/6
- visual stereoscopy > 50
- standard visual field
Who cannot join
- pregnancy or breast feeding
- use of any drug or St John's wort
- smoking
- asthma
- pulmonary obstruction
- cardiovascular impairment
Show all 11Show fewer
- attention troubles
- ocular diseases
- epilepsy
- lactose intolerance
- absorption of grapefruit juice
Trial locations and contacts
1 site in 1 country.
Canada1 site
School of optometry / Université de Montréal
Montreal, Quebec, H3T 1P1
About this study
Official title: Donepezil Effect on Visual Attention and Perceptual Training in Healthy Young Adults
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.
Read the detailed description
Stages of a given perceptual-cognitive task (from Faubert and Sidebottom, Journal of Clinical Sport Psychology, 2012, 6, 85-102):
- a predetermined number of spheres (typically eight) are presented in a 3D dimensional virtual volumetric cube space. The spheres are typically all identical.
- a subset of spheres (typically four) is indexed via highlighting for a brief period of 1 s.
- 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.
- 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.
- Conditions
- Healthy
- Being tested
- Donepezil administration, Placebo administration
- Keywords
- acetylcholine, cholinergic system, visual perception, visual attention, multiple objects tracking, perceptual learning, vision training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil administrationDrug
Also called Aricept, Pfizer
Placebo administrationDrug
Also called Lactose pill
| Study group | Role | What they receive |
|---|---|---|
| Donepezil | Active comparator | Donepezil administration. In this group Donepezil (Aricept pill, 5 mg) will be orally administrated 3h before each experiment (1 week intervals) Receives: 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) Receives: Drug: Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvire Vaucher, Université de Montréal
- Investigators
- Elvire Vaucher, PhD, Study director, Université de MontréalJocelyn Faubert, PhD, Study director, Université de MontréalIsabelle Legault, PhD, Principal investigator, Université de MontréalMira Chamoun, MSc, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738295
- Sponsor's protocol ID
- 12-084-CERES
- Status last verified
- Aug 2015
- First submitted
- 20 Nov 2012
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil Effect on Visual Attention and Perceptual Training in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT01738295
- Acronym / sponsor ID
- 12-084-CERES
- Conditions
- Healthy
- Keywords
- acetylcholine, cholinergic system, visual perception, visual attention, multiple objects tracking, perceptual learning, vision training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stages of a given perceptual-cognitive task (from Faubert and Sidebottom, Journal of Clinical Sport Psychology, 2012, 6, 85-102):
- a predetermined number of spheres (typically eight) are presented in a 3D dimensional virtual volumetric cube space. The spheres are typically all identical.
- a subset of spheres (typically four) is indexed via highlighting for a brief period of 1 s.
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil | Active comparator | Drug: Donepezil administrationDonepezil administration. In this group Donepezil (Aricept pill, 5 mg) will be orally administrated 3h before each experiment (1 week intervals) |
| Lactose pill | Placebo comparator | Drug: Placebo administrationPlacebo administration. In this group, placebo (lactose pill) will be orally administrated 3h before each experiments (1 week intervals) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- good general health
- 17 < body mass index < 25
- visual acuity 6/6
- visual stereoscopy > 50
- standard visual field
Key exclusion criteria (11 listed)
- pregnancy or breast feeding
- use of any drug or St John's wort
- smoking
- asthma
- pulmonary obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil administrationAlso: Aricept, Pfizer | Drug | Donepezil |
| Placebo administrationAlso: Lactose pill | Drug | Lactose pill |
Primary outcome
Measure of the speed threshold, baseline
Time frame: week 0
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
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvire Vaucher, PhD study director
Université de Montréal
Jocelyn Faubert, PhD study director
Université de Montréal
Isabelle Legault, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donepezil administration in people with Healthy, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the speed threshold, baseline (time frame: week 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.