NCT05820932

Predicting Cognitive Decline From Androgen Deprivation Therapy

Plasma Amyloid-beta 42/40 to Predict Cognitive Decline From Androgen Deprivation Therapy in Prostate Cancer: a Prospective Observational Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Androgen Deprivation Therapy (ADT) is associated with cognitive impairment and dementia in men with prostate cancer. Pre-clinical data suggest that ADT-induced hypogonadism leads to accumulation of beta-amyloid plaques in the hippocampus, a pathological hallmark of Alzheimer's Disease (AD). Neuroimaging Functional magnetic resonance imaging (fMRI) studies also demonstrate that ADT decreases metabolic activity in the parietal, occipital, and prefrontal cortices. Multiple prospective cohort and population-based clinical studies have been conducted to test the association between ADT and cognitive impairment and/or dementia. Plasma biomarkers have been developed to predict brain amyloidosis, a key pathological feature of AD and a risk factor for developing dementia due to AD. The advantage of a blood-based assay is the lower cost, invasiveness, and time compared to cerebrospinal fluid (CSF) and Positron Emission Tomography (PET)-based biomarkers.

Detailed description

This is a single-site, non-randomized prospective observational study of men with prostate cancer. PRIMARY OBJECTIVE: I. To evaluate whether baseline plasma Amyloid-beta 42/40 (Aβ42/40) ratio is associated with cognitive decline in men upon starting ADT. SECONDARY OBJECTIVE: I. To evaluate whether ADT is associated with a decline in plasma Aβ42/40 ratio. II. To evaluate whether intensified ADT (iADT) receipt is associated with greater cognitive decline compared to ADT.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
GENETIC	Blood-based assay	Blood samples will be collected
DIAGNOSTIC_TEST	Cognitive assessments	Cognitive assessments will be both participant- and partner-reported
OTHER	Quality of Life Surveys	Participant-reported Quality of Life Surveys

Timeline

• Start date: 2023-05-22
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2023-04-20
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States