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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Genetic Disorder; Anxiety Disorder; Depression; Malignant Solid Neoplasm

Treatments: Other: Electronic Health Record Review

Study type: Observational

Funder types: Other

Identifiers

NCT04743466

NCI-2020-13782 (Registry Identifier)

2019-1061 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

700,000 participants in 1 patient group

Observational (biobank review)

Description:

Patients' records from institutional or national biobanks are reviewed.

Treatment:

Other: Electronic Health Record Review