Visual PerceptionEarly Phase 1NCT05003063
Effects of Acetylcholine and Attention on Visual Spatial Representations in the Brain
A Early Phase 1 study testing Donepzil in people with Visual Perception and Attention, run by University of California, Berkeley at 1 site in United States.
Trial summary
This study in, healthy human subjects using fMRI and MRS (magnetic resonance spectroscopy) characterizes, how attention and acetylcholine affect visual perception and the brain's representation of the visual environment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Perception, Attention, Information Processing
- What is being tested?
- Donepzil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2021to 2 Aug 2021
- Phase
- Early Phase 1
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult individuals
Who cannot join
- Pregnancy
- Asthma/lung problems
- Certain medications, seizure
- Failure to complete Donepezil (Aricept) Contraindications Screening Sheet
- Previous long term exposure to nicotine/tobacco products, individuals with pacemakers, cosmetics, or certain metallic implants in their bodies will be excluded from experiments involving MRI recording.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
This study in, healthy human subjects using fMRI and MRS (magnetic resonance spectroscopy) characterizes, how attention and acetylcholine affect visual perception and the brain's representation of the visual environment. Levels of acetylcholine in the cerebral cortex will be enhanced by administration of donepezil, an inhibitor of acetylcholinesterase. Half the subjects will receive donepezil and other half will receive placebo.
Read the detailed description
The long-term objective of this project is to characterize how attention and acetylcholine affect visual perception and the brain's representation of the visual environment. Acetylcholine is a naturally occurring neurotransmitter, and acetylcholine release is elevated during periods of sustained attention. Both acetylcholine and attention enhance aspects of visual perception, but the underlying brain mechanisms are poorly understood. The proposed work will address these questions in healthy human subjects by using functional magnetic resonance imaging (fMRI) and MRS (magnetic resonance spectroscopy) to measure the brain's responses to visual stimuli. Our previous studies have shown that increasing levels of acetylcholine in the brain enhances the spatial resolution of the brain's representation of the visual environment. The proposed research will document exactly which brain areas mediate this effect of acetylcholine and will also characterize the effects of attention on these measures of spatial resolution in the brain.
The technique of fMRI (functional magnetic resonance imaging) and MRS (magnetic resonance spectroscopy), both subtypes of MRI, will be employed to measure brain activity in different brain areas while subjects are performing a visual attention task. Levels of acetylcholine in the cerebral cortex will be enhanced by administration of donepezil, an inhibitor of acetylcholinesterase, the enzyme that metabolizes acetylcholine. Moreover, the technique of MRS will be employed to locally quantify the levels of acetylcholine in different brain areas.
In addition to providing information about how attention is represented in the brain and how it affects processing of visual stimuli, the present experiments should also shed light on the function of the cholinergic projection from the basal forebrain to the cerebral cortex. As this projection is thought to be selectively impaired in Alzheimer's disease, knowledge concerning its function in the healthy brain may be useful for understanding the etiology of this disease and for development of appropriate therapies.
BEHAVIORAL PHARMACOLOGY:
Sessions:
Subjects will perform 6 behavioral sessions over several days outside the scanner, split into two experimental parts. There will be 2 baseline sessions without donepezil/placebo and 4 testing sessions with donepezil/placebo. Each behavioral (outside the scanner) session will last 1-2 hours. During the testing session, subjects will be given one pill of (2.5 or 5 or 10mg) donepezil or placebo per session. The choice of the pill will be determined by the flip of a coin. The drug dosage (2.5 or 5 or 10mg) will be determined so as to ensure that there are equal number of participants per drug dosage. The pill (drug or placebo) not selected for the first experimental session in a pair will be administered during the second experimental session.
Task:
A typical cognitive task will involve presentation of images or words on a computer monitor or sounds through headphones. The subjects are asked to respond to certain stimuli by pressing a button. All stimuli are presented at a comfortable level. The cognitive task performed during the behavioral is an object-tracking/target detection paradigm in which subjects indicate whether a target is presented or not on each experimental trial. The target, when it is presented, is a visual stimulus at the threshold of detectability. On some trials, subjects will receive cues indicating target location and/or features that will facilitate target detection. Subjects will be asked to report by pressing a button on a response box. Subjects will receive breaks every 5-10 minutes or more frequently if they desire.
MRI AND PHARMACOLOGY:
Sessions:
For experiments involving MRI, there will be a total of 6 sessions across several days, split into two experimental parts. There will be two baseline MRI session without donepezil/placebo and 4 testing sessions (two donepezil, two placebo). Subjects will be given one pill of (2.5 or 5 or 10mg) donepezil or placebo per session. The choice of the pill will be determined by the flip of a coin. The pill not selected for the first experimental part will be administered during the second experimental part.
For MRI experiments, the experimenter will escort the subject to the Brain Imaging Center in Li Ka Shing about 2.5 hours after pill administration, and fMRI measurements will begin approximately 3 hours after pill administration. The MRI sessions typically take 1-2.5 hours, and the subject is given frequent breaks. The subject may stop the experiment at any time. Subjects undergoing MRI scanning will be asked to lie on their back in the MRI scanner. Before being scanned, a MRI imaging coil made of plastic will be placed around the subject's head. The subject will not come into contact with the coil during the experiment. Foam pads will be placed around the subject's head to limit head movement during the study.
Task:
A typical cognitive task will involve presentation of images or words on a computer monitor or sounds through headphones. The subjects are asked to respond to certain stimuli by pressing a button. All stimuli are presented at a comfortable level. The cognitive task performed during the behavioral is an object-tracking/target detection paradigm in which subjects indicate whether a target is presented or not on each experimental trial. The target, when it is presented, is a visual stimulus at the threshold of detectability. On some trials, subjects will receive cues indicating target location and/or features that will facilitate target detection. Subjects will be asked to report by pressing a button on a response box. Subjects will receive breaks every 5-10 minutes or more frequently if they desire.
- Being tested
- Donepzil, Placebo oral tablet
- Keywords
- Attention, Visual Perception, Cholinergic system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepzilDrug
Test
Placebo oral tabletDrug
Test
| Study group | Role | What they receive |
|---|---|---|
| Donepezil | Active comparator | 5mg Donepezil will be administered in pill form. Receives: Drug: Donepzil |
| Placebo | Placebo comparator | 5mg placebo will be administered in pill form. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population receptive field (pRF) size
measuring pRF size changes due to donepezil intervention
Measured: Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.
Secondary outcomes (2)
Population receptive field (pRF) eccentricity
measuring pRF eccentricity changes due to donepezil intervention
Measured: Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.
Response amplitude
measuring Response amplitude changes due to donepezil intervention
Measured: Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start4 Feb 2021
- Primary completion2 Aug 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual PerceptionStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003063
- Sponsor's protocol ID
- 2018-10-11532
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acetylcholine and Attention on Visual Spatial Representations in the Brain
- ClinicalTrials.gov ID
- NCT05003063
- Acronym / sponsor ID
- 2018-10-11532
- Keywords
- Attention, Visual Perception, Cholinergic system
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 12 Aug 2021 (actual)
- 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.
This study in, healthy human subjects using fMRI and MRS (magnetic resonance spectroscopy) characterizes, how attention and acetylcholine affect visual perception and the brain's representation of the visual environment. Levels of acetylcholine in the cerebral cortex will be enhanced by administration of donepezil, an inhibitor of acetylcholinesterase. Half the subjects will receive donepezil and other half will receive placebo.
Detailed description
The long-term objective of this project is to characterize how attention and acetylcholine affect visual perception and the brain's representation of the visual environment. Acetylcholine is a naturally occurring neurotransmitter, and acetylcholine release is elevated during periods of sustained attention. Both acetylcholine and attention enhance aspects of visual perception, but the underlying brain mechanisms are poorly understood. The proposed work will address these questions in healthy human subjects by using functional magnetic resonance imaging (fMRI) and MRS (magnetic resonance spectroscopy) to measure the brain's responses to visual stimuli. Our previous studies have shown that increasing levels of acetylcholine in the brain enhances the spatial resolution of the brain's representation of the visual environment. The proposed research will document exactly which brain areas mediate this effect of acetylcholine and will also characterize the effects of attention on these measures of spatial resolution in the brain.
The technique of fMRI (functional magnetic resonance imaging) and MRS (magnetic resonance spectroscopy), both subtypes of MRI, will be employed to measure brain activity in different brain areas while subjects are performing a visual attention task. Levels of acetylcholine in the cerebral cortex will be enhanced by administration of donepezil, an inhibitor of acetylcholinesterase, the enzyme that metabolizes acetylcholine. Moreover, the technique of MRS will be employed to locally quantify the levels of acetylcholine in different brain areas.
In addition to providing information about how attention is represented in the brain and how it affects processing of visual stimuli, the present experiments should also shed light on the function of the cholinergic projection from the basal forebrain to the cerebral cortex. As this projection is thought to be selectively impaired in Alzheimer's disease, knowledge concerning its function in the healthy brain may be useful for understanding the etiology of this disease and for development of appropriate therapies.
BEHAVIORAL PHARMACOLOGY:
Sessions:
Subjects will perform 6 behavioral sessions over several days outside the scanner, split into two experimental parts. There will be 2 baseline sessions without donepezil/placebo and 4 testing sessions with donepezil/placebo. Each behavioral (outside the scanner) session will last 1-2 hours. During the testing session, subjects will be given one pill of (2.5 or 5 or 10mg) donepezil or placebo per session. The choice of the pill will be determined by the flip of a coin. The drug dosage (2.5 or 5 or 10mg) will be determined so as to ensure that there are equal number of participants per drug dosage. The pill (drug or placebo) not selected for the first experimental session in a pair will be administered during the second experimental session.
Task:
A typical cognitive task will involve presentation of images or words on a computer monitor or sounds through headphones. The subjects are asked to respond to certain stimuli by pressing a button. All stimuli are presented at a comfortable level. The cognitive task performed during the behavioral is an object-tracking/target detection paradigm in which subjects indicate whether a target is presented or not on each experimental trial. The target, when it is presented, is a visual stimulus at the threshold of detectability. On some trials, subjects will receive cues indicating target location and/or features that will facilitate target detection. Subjects will be asked to report by pressing a button on a response box. Subjects will receive breaks every 5-10 minutes or more frequently if they desire.
MRI AND PHARMACOLOGY:
Sessions:
For experiments involving MRI, there will be a total of 6 sessions across several days, split into two experimental parts. There will be two baseline MRI session without donepezil/placebo and 4 testing sessions (two donepezil, two placebo). Subjects will be given one pill of (2.5 or 5 or 10mg) donepezil or placebo per session. The choice of the pill will be determined by the flip of a coin. The pill not selected for the first experimental part will be administered during the second experimental part.
For MRI experiments, the experimenter will escort the subject to the Brain Imaging Center in Li Ka Shing about 2.5 hours after pill administration, and fMRI measurements will begin approximately 3 hours after pill administration. The MRI sessions typically take 1-2.5 hours, and the subject is given frequent breaks. The subject may stop the experiment at any time. Subjects undergoing MRI scanning will be asked to lie on their back in the MRI scanner. Before being scanned, a MRI imaging coil made of plastic will be placed around the subject's head. The subject will not come into contact with the coil during the experiment. Foam pads will be placed around the subject's head to limit head movement during the study.
Task:
A typical cognitive task will involve presentation of images or words on a computer monitor or sounds through headphones. The subjects are asked to respond to certain stimuli by pressing a button. All stimuli are presented at a comfortable level. The cognitive task performed during the behavioral is an object-tracking/target detection paradigm in which subjects indicate whether a target is presented or not on each experimental trial. The target, when it is presented, is a visual stimulus at the threshold of detectability. On some trials, subjects will receive cues indicating target location and/or features that will facilitate target detection. Subjects will be asked to report by pressing a button on a response box. Subjects will receive breaks every 5-10 minutes or more frequently if they desire.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil | Active comparator | Drug: Donepzil5mg Donepezil will be administered in pill form. |
| Placebo | Placebo comparator | Drug: Placebo oral tablet5mg placebo will be administered in pill form. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult individuals
Key exclusion criteria (5 listed)
- Pregnancy
- Asthma/lung problems
- Certain medications, seizure
- Failure to complete Donepezil (Aricept) Contraindications Screening Sheet
- Previous long term exposure to nicotine/tobacco products, individuals with pacemakers, cosmetics, or certain metallic implants in their bodies will be excluded from experiments involving MRI recording.
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 |
|---|---|---|
| DonepzilTest | Drug | Donepezil |
| Placebo oral tabletTest | Drug | Placebo |
Primary outcome
Population receptive field (pRF) size
Time frame: Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.
measuring pRF size changes due to donepezil intervention
2 secondary outcomes
Population receptive field (pRF) eccentricity
Time frame: Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.
Response amplitude
Time frame: Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.
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 12 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Donepzil in people with Visual Perception and Attention, run by University of California, Berkeley at 1 site in United States.
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 1 inclusion and 5 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 12 Aug 2021. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Population receptive field (pRF) size (time frame: Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.). 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 12 Aug 2021.