Breast CancerNCT05635357
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole
An observational study of Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole and Exemestane/Letrozole
- How many people
- 16,989 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: This 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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Anastrozole, Exemestane/Letrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Anastrozole claim is used as the exposure group.
Exemestane/LetrozoleDrug
Exemestane/Letrozole claim is used as the reference group.
| Study group | Role | What they receive |
|---|---|---|
| Anastrozole | Exposure group Receives: Drug: Anastrozole | |
| Exemestane/Letrozole | Reference group Receives: Drug: Exemestane/Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 years
Secondary outcomes (1)
Time to Alzheimer's disease onset
Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.
Measured: up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Nov 2022
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 16,989 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Rutgers University, Johns Hopkins University
- Responsible party
- Principal investigator, Rishi J. Desai, Brigham and Women's Hospital
- Investigators
- Madhav Thambisetty, MD, PhD, Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635357
- Sponsor's protocol ID
- 2019P003607-11
- Status last verified
- Jul 2025
- First submitted
- 21 Nov 2022
- Last updated
- 28 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole
- ClinicalTrials.gov ID
- NCT05635357
- Acronym / sponsor ID
- 2019P003607-11
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,989 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Rutgers University, Johns Hopkins University
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastrozole | – | Drug: AnastrozoleExposure group |
| Exemestane/Letrozole | – | Drug: Exemestane/LetrozoleReference group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnastrozoleAnastrozole claim is used as the exposure group. | Drug | Anastrozole |
| Exemestane/LetrozoleExemestane/Letrozole claim is used as the reference group. | Drug | Exemestane/Letrozole |
Primary outcome
Time to dementia onset
Time frame: 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.
1 secondary outcome
Time to Alzheimer's disease onset
Time frame: up to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhav Thambisetty, MD, PhD principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to dementia onset (time frame: up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.