Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05635357

Enrollment

16989

Registered

2022-12-02

Start date

2022-11-01

Completion date

2023-12-31

Last updated

2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Detailed description

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. 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 using healthcare claims data.

Interventions

DRUGAnastrozole

Anastrozole claim is used as the exposure group.

DRUGExemestane/Letrozole

Exemestane/Letrozole claim is used as the reference group.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Please see https://docs.google.com/spreadsheets/d/1GrnVsPCockqqdfxC9LWd6ndbzS2wpJVvTbCOAhn4DLM/edit?usp=sharing or Appendix A (https://drive.google.com/drive/folders/1I8FVmpPzC5wQN9DFIv1Rbwh1N0SLEv0B?usp=sharing) for full code and algorithm definitions. Medicare timeframe: 2008 to 2018 (end of data availability) Inclusion Criteria: * 1\. Aged \>/= 65 years on the index date * 2\. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date * 3\. At least two claims with breast cancer diagnosis measured 365 days prior to drug initiation

Exclusion criteria

* 1\. Prior history of dementia measured anytime prior to cohort entry date * 2\. Prior history of nursing home admission anytime prior to cohort entry date * 3\. Prior history of Anastrozole or Exemestane/Letrozole use anytime prior to cohort entry date

Design outcomes

Primary

Measure	Time frame	Description
Time to dementia onset	up to 6 years	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.

Secondary

Measure	Time frame	Description
Time to Alzheimer's disease onset	up to 6 years	Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026