NCT05635357|CompletedFDA Drug
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Sponsor study identifier
observational
16,989
1 country
1
Study Start
November 1, 2022
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2022
Actual (reported)November 21, 2022
Actual (reported)December 2, 2022
Actual (reported)June 30, 2023
Actual (reported)December 31, 2023
Actual (reported)Time to dementia onset
Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations.
up to 6 years
Time to Alzheimer's disease onset
up to 6 years
Exposure group
Reference group
Anastrozole claim is used as the exposure group.
Exemestane/Letrozole claim is used as the reference group.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Exemestane/Letrozole
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordThis study will employ a new user, active comparator, observational cohort study design comparing Anastrozole vs Exemestane/Letrozole. The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (cohort entry/index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).
Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
Madhav Thambisetty, MD, PhD
National Institute on Aging (NIA)
16,989 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2022
First Posted
December 2, 2022
Study Start
November 1, 2022
Actual (reported)Aromatase Inhibitors in Premenopausal Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)Last Updated
July 28, 2025
Record last verified: 2025-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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