NCT05003063

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

August 6, 2021

Last Update Submit

August 6, 2021

Conditions

Visual PerceptionAttentionInformation ProcessingCholinergic System

Keywords

AttentionVisual PerceptionCholinergic system

Outcome Measures

Primary Outcomes (1)

  • Population receptive field (pRF) size

    measuring pRF size changes due to donepezil intervention

    Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.

Secondary Outcomes (2)

  • Population receptive field (pRF) eccentricity

    Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.

  • Response amplitude

    Starting 3 hours after pill administration. 1 functional scan every 4 minutes for one hour.

Study Arms (2)

Donepezil

ACTIVE COMPARATOR

5mg Donepezil will be administered in pill form.

Drug: Donepzil

Placebo

PLACEBO COMPARATOR

5mg placebo will be administered in pill form.

Drug: Placebo oral tablet

Interventions

DonepzilDRUG

Test

Donepezil
Placebo oral tabletDRUG

Test

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult individuals

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study will be double blind
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 12, 2021

Study Start

February 4, 2021

Primary Completion

August 2, 2021

Study Completion

August 2, 2021

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

US(1)