Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes

NCT ID: NCT04743466

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-13

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Anxiety Disorder Depression Genetic Disorder Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational (biobank review)

Patients' records from institutional or national biobanks are reviewed.

Electronic Health Record Review

Intervention Type OTHER

Biobank records are reviewed

Interventions

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Electronic Health Record Review

Biobank records are reviewed

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Nead

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Kevin Nead

Role: primary

713-563-5155

Other Identifiers

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NCI-2020-13782

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-1061

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1061

Identifier Type: -

Identifier Source: org_study_id

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