Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604520
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Vortioxetine for the Treatment of Mood and Cognitive Symptoms in Frontotemporal Dementia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Functional Neuroimaging to Examine Affective Symptoms and Cognition in Frontotemporal Dementia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if vortioxetine improves mood symptoms and cognition in patients with early-stage behavioral variant Frontotemporal Dementia bvFTD The main questions this study aims to answer are
1 Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD
2 Do mood symptoms and cognition improve following treatment with vortioxetine
Researchers will also determine whether there are changes in the brain associated with vortioxetine treatment
Participants will
Undergo a screening visit that involves clinical assessments and laboratory tests
Undergo an initial brain magnetic resonance imaging MRI and fluorodeoxyglucose 18F Positron Emission Tomography FDG PET scan before starting treatment with vortioxetine
Undergo memory and problem-solving tests before starting treatment with vortioxetine
Undergo approximately 12 weeks of treatment with vortioxetine during which time there will be regular contact and assessments with the study psychiatrist
Undergo a repeat PET scan and repeat memory and problem-solving tests after 12 weeks of treatment with vortioxetine
1 Do individuals with mood symptoms and bvFTD have brain changes and cognitive profiles that differ compared to individuals without bvFTD
2 Do mood symptoms and cognition improve following treatment with vortioxetine
Researchers will also determine whether there are changes in the brain associated with vortioxetine treatment
Participants will
Undergo a screening visit that involves clinical assessments and laboratory tests
Undergo an initial brain magnetic resonance imaging MRI and fluorodeoxyglucose 18F Positron Emission Tomography FDG PET scan before starting treatment with vortioxetine
Undergo memory and problem-solving tests before starting treatment with vortioxetine
Undergo approximately 12 weeks of treatment with vortioxetine during which time there will be regular contact and assessments with the study psychiatrist
Undergo a repeat PET scan and repeat memory and problem-solving tests after 12 weeks of treatment with vortioxetine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None