Clinical trial · Observational
Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes
Evaluation of a Causal Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes: A Mendelian Randomization Analysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Genetic Disorder | — | UNRESOLVED | — |
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Health Record Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (biobank review)
- description
- Patients' records from institutional or national biobanks are reviewed.
- interventionNames
- Other: Electronic Health Record Review
Primary outcomes (1)
- measure
- Association between germline genetic predictors (single nucleotide variants) of lower testosterone levels and dementia risk
- timeFrame
- Up to 2 years
- description
- 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 outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available