Healthy Volunteer
Conditions
Brief summary
This is a single center non-interventional study in healthy participants for behavioral assessment and fMRI assessments. The study will consist of 2 parts. Part A will involve 5 participants and will study the implementation of the behavioral tests and identify potential issues. Part B will involve 30 participants and will study the test-retest reliability. Duration of participation for each participant will be 30 days for Part A (28 days screening period and 2 days of study visit) and 48 days for Part B (28 days screening period and 2 study visits of 2 days each separated by a period of 14 days).
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants, as determined by screening assessments and principal investigator judgment * A body mass index (BMI) between 18 to 30 kilogram per square meter (kg/m\^2) inclusive with body weight in the range of 50 to 100 kg * The participant must be able to comply with study requirements as judged by the principal investigator * Women participants who are not postmenopausal or surgically sterile agree to use effective contraception throughout the study
Exclusion criteria
* Female participant with child-bearing potential or a positive blood pregnancy test * Lactating women participants * Any history of alcohol and/or drug abuse, addiction or suspicion of regular consumption of drugs of abuse * Use of any psychoactive medication, or medications known to have effect on central nervous system (CNS) or blood flow * Any contraindications for magnetic resonance imaging (MRI) scans or any brain/head abnormalities restricting MRI eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra Class Coefficient of Correlation (ICC) of the Task Activated Blood Oxygenation Level-Dependent (BOLD) fMRI: Face Matching Task | Day 1 |
| ICC of the Task Activated BOLD fMRI: Monetary Incentive Delay Task | Day 1 |
| ICC of the Task Activated BOLD fMRI: 2 vs 0 Back Working Memory Task | Day 1 |
| ICC of the Task Activated BOLD fMRI: Episodic memory Task (Encoding, Recall, and Recognition of Face-Profession Pairs) | Day 1 |
| ICC of the Task Activated BOLD fMRI: Theory of Mind Task (ToM; To Make Inferences About Others Mental States Using 32 False-Belief Cartoon Stories) | Day 1 |
| ICC of the Resting-State BOLD fMRI, Acquired Using Gradient Echo-Planar Imaging (EPI) Images | Screening (Day -28 to Day -1) |
| ICC of the Resting-State Arterial Spin Labeling (ASL) to Measure Cerebral Blood Flow, Acquired Using Gradient EPI Images | Screening (Day -28 to Day -1) |
| ICC of the out of Scanner Behavioral Tasks: Stop Signal Reaction Time (SSRT) to Assess the Time Required to Stop Already Executed Response | Day 1 |
| ICC of the out of Scanner Behavioral Tasks: California Verbal Learning Test - Second Edition (CVLT-II), to Assess an Individual's Episodic Verbal Learning and Memory Abilities | Day 2 |
| Out of Scanner Behavioral Tasks: RAVEN General Intelligence Test | Screening (Day -28 to Day -1) |
| ICC of the out of Scanner Behavioral Tasks: Emotional Test Battery (ETB), Assessed Using Facial Expression Recognition Task (FERT) and Faces Dot Probe Task (FDOT) to Measure Biases in Emotional Processing | Day 1 |
| ICC of the out of Scanner Behavioral Tasks: Reward Learning Tasks (Reinforcement Learning and Working Memory Task) | Day 2 |
| ICC of the Task Activated BOLD fMRI: Go/No-Go Task | Day 1 |
Countries
Netherlands
Outcome results
None listed