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

NCT04743466 | Active Not Recruiting

• 2 other identifiers: 2019-1061NCI-2020-13782
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Association between germline genetic predictors (single nucleotide variants) of lower testosterone levels and dementia risk

  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).

  Up to 2 years

Secondary Outcomes (3)

• Depression

  Up to 2 years

• Anxiety

  Up to 2 years

• Cognitive/mental health

  Up to 2 years

Study Arms (1)

Observational (biobank review)

Patients' records from institutional or national biobanks are reviewed.

Other: Electronic Health Record Review

Interventions

Electronic Health Record Review OTHER

Biobank records are reviewed

Observational (biobank review)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals have volunteered to participate in institutional or national biobanks

You may qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Genetic Diseases, Inborn; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kevin Nead

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: February 13, 2020
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)