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Trial record 1 of 6 for:    testosterone | dementia | Studies with Female Participants
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Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes

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ClinicalTrials.gov Identifier: NCT04743466
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : February 15, 2024
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Anxiety Disorder Depression Genetic Disorder Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Electronic Health Record Review

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 700000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Evaluation of a Causal Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes: A Mendelian Randomization Analysis
Actual Study Start Date : February 13, 2020
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (biobank review)
Patients' records from institutional or national biobanks are reviewed.
 Other: Electronic Health Record Review
Biobank records are reviewed


Outcome Measures
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Primary Outcome Measures :
  1. Association between germline genetic predictors (single nucleotide variants) of lower testosterone levels and dementia risk [ Time Frame: Up to 2 years ]
    Will utilize genetic variants associated with testosterone levels at genome-wide statistical significance thresholds (P < 5 x 10-8) in published meta-analyses. Will additionally conduct a genome-wide association study with testosterone values in the UK Biobank. Will construct a weighted genetic risk score based on the strength of each variant's association with testosterone levels in published datasets. The results of the weighted method will be scaled per standard deviation (SD) of testosterone levels so that effect sizes represent the odds ratio of the outcome (e.g. dementia) per genetically predicted SD decrease in testosterone levels. Will also utilize risk scores with less stringent significance thresholds in secondary analyses (P < 5 x 10-6).


Secondary Outcome Measures :
  1. Depression [ Time Frame: Up to 2 years ]
    Association between low testosterone levels and depression will be examined. Will construct a weighted genetic risk score based on the strength of each variant's association with testosterone levels in published datasets. The results of the weighted method will be scaled per standard deviation (SD) of testosterone levels so that effect sizes represent the odds ratio of the outcome (e.g. dementia) per genetically predicted SD decrease in testosterone levels. Will also utilize risk scores with less stringent significance thresholds in secondary analyses (P < 5 x 10-6).

  2. Anxiety [ Time Frame: Up to 2 years ]
    Association between low testosterone levels and anxiety will be examined. Will construct a weighted genetic risk score based on the strength of each variant's association with testosterone levels in published datasets. The results of the weighted method will be scaled per standard deviation (SD) of testosterone levels so that effect sizes represent the odds ratio of the outcome (e.g. dementia) per genetically predicted SD decrease in testosterone levels. Will also utilize risk scores with less stringent significance thresholds in secondary analyses (P < 5 x 10-6).

  3. Cognitive/mental health [ Time Frame: Up to 2 years ]
    Association between low testosterone levels and cognitive/mental health will be examined. Will construct a weighted genetic risk score based on the strength of each variant's association with testosterone levels in published datasets. The results of the weighted method will be scaled per standard deviation (SD) of testosterone levels so that effect sizes represent the odds ratio of the outcome (e.g. dementia) per genetically predicted SD decrease in testosterone levels. Will also utilize risk scores with less stringent significance thresholds in secondary analyses (P < 5 x 10-6).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals have volunteered to participate in institutional or national biobanks
Criteria

Inclusion Criteria:

  • Have volunteered to participate in institutional or national biobanks, mainly the UK Biobank and the Kaiser Permanente Research Bank, and those that have previously participated in studies that resulted in de-identified clinical and genetic data being make available on public archives, mainly the database of Genotypes and Phenotypes (dbGaP)
  • No special populations (adults unable to consent, individuals not yet adults, pregnant women, or prisoners)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743466


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Kevin Nead    713-563-5155    ktnead@mdanderson.org   
Principal Investigator: Kevin Nead         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Kevin Nead M.D. Anderson Cancer Center
More Information
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04743466    
Other Study ID Numbers: 2019-1061
NCI-2020-13782 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-1061 ( Other Identifier: M D Anderson Cancer Center )
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Dementia
Genetic Diseases, Inborn
Anxiety Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders