Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-30 @ 4:17 AM
Study NCT ID:
NCT04743466
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2021-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Evaluation of a Causal Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes: A Mendelian Randomization Analysis
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the association between testosterone levels and risk of dementia and adverse mental health outcomes (e.g. depression and anxiety). It is not known whether low testosterone levels may be associated with an increased risk of dementia. Learning about the association between testosterone levels and risk of dementia may help determine the long-term effects of androgen deprivation therapy and may help improve quality of life.
Detailed Description:
PRIMARY OBJECTIVE:
I. To use a Mendelian randomization study design to determine whether genetically predicted decreased testosterone levels are associated with an increased risk of dementia.
SECONDARY OBJECTIVE:
I. To examine whether genetically predicted decreased testosterone levels are associated with worse cognitive function and adverse mental health outcomes.
OUTLINE:
Patients' records from institutional or national biobanks are reviewed.
I. To use a Mendelian randomization study design to determine whether genetically predicted decreased testosterone levels are associated with an increased risk of dementia.
SECONDARY OBJECTIVE:
I. To examine whether genetically predicted decreased testosterone levels are associated with worse cognitive function and adverse mental health outcomes.
OUTLINE:
Patients' records from institutional or national biobanks are reviewed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: