Pulmonary Arterial HypertensionNCT05039086
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5
An observational study of Pulmonary Arterial Hypertension, 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 older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- PDE5 inhibitor and Endothelin Receptor Antagonists
- How many people
- 13,021 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 4 Oct 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Older adult
Study population: This study will employ a new user, active comparator, observational cohort study design comparing PDE5 inhibitors (sildenafil, tadalafil) to endothelin receptor antagonists (bosentan, ambrisentan, macitentan). 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. No prior use of PDE5 inhibitors (sildenafil, tadalafil) and endothelin receptor antagonists (bosentan, ambrisentan, macitentan) anytime prior to cohort entry date
- 3. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
Who cannot join
- 1. Prior history of dementia measured anytime prior to cohort entry date
- 2. No prior history of pulmonary arterial hypertension recorded in the 365 days prior to cohort entry date
- 3. Prior history of nursing home admission in the 365 days prior to the 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
Official title: Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- PDE5
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
- Pulmonary Arterial Hypertension
- Being tested
- PDE5 inhibitor, Endothelin Receptor Antagonists
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDE5 inhibitorDrug
PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.
Endothelin Receptor AntagonistsDrug
Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.
| Study group | Role | What they receive |
|---|---|---|
| PDE5 inhibitors | Exposure group Receives: Drug: PDE5 inhibitor | |
| Endothelin receptor antagonists | Reference group Receives: Drug: Endothelin Receptor Antagonists |
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 includes: 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.
Analysis 1-'as-treated' follow-up approach: In this approach, we followed patients from cohort entry until treatment discontinuation or switch to the comparator treatment, insurance disenrollment, death, or administrative endpoint (December 2018). Treatment discontinuation was defined as occurring 90 days after the expected days supply.
of the most recently filled prescription to accommodate suboptimal adherence during treatment periods.
Analysis 2-'as-started' follow-up approach incorporating a 6-month 'induction' period.
Analysis 3-incorporating a 6-month 'symptoms to diagnosis' period Analysis 4-high-specificity outcome definition
Study accessed Medicare files (Jan 2008-Dec 2018) between September 1, 2021 to October 4, 2022.
Measured: Median follow up times: 1) 168 days (exp), 151 days (ref) 2) 693 days (exp), 720 days (ref) 3) 382 days (exp), 358 days (ref) 4) 169 days (exp), 151 days (ref)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Sep 2021
- Primary completion30 Sep 2021
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies 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
- 13,021 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
- NCT05039086
- Sponsor's protocol ID
- 2019A010961-8
- Status last verified
- Jul 2025
- First submitted
- 1 Sep 2021
- Last updated
- 6 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 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)- PDE5
- ClinicalTrials.gov ID
- NCT05039086
- Acronym / sponsor ID
- 2019A010961-8
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,021 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 Sep 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Posted 20 Feb 2024
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 |
|---|---|---|
| PDE5 inhibitors | – | Drug: PDE5 inhibitorExposure group |
| Endothelin receptor antagonists | – | Drug: Endothelin Receptor AntagonistsReference group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- This study will employ a new user, active comparator, observational cohort study design comparing PDE5 inhibitors (sildenafil, tadalafil) to endothelin receptor antagonists (bosentan, ambrisentan, macitentan). 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. No prior use of PDE5 inhibitors (sildenafil, tadalafil) and endothelin receptor antagonists (bosentan, ambrisentan, macitentan) anytime prior to cohort entry date
- 3. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
Key exclusion criteria (3 listed)
- 1. Prior history of dementia measured anytime prior to cohort entry date
- 2. No prior history of pulmonary arterial hypertension recorded in the 365 days prior to cohort entry date
- 3. Prior history of nursing home admission in the 365 days prior to the 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 |
|---|---|---|
| PDE5 inhibitorPDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group. | Drug | PDE5 inhibitors |
| Endothelin Receptor AntagonistsEndothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group. | Drug | Endothelin receptor antagonists |
Primary outcome
Time to Dementia Onset
Time frame: Median follow up times: 1) 168 days (exp), 151 days (ref) 2) 693 days (exp), 720 days (ref) 3) 382 days (exp), 358 days (ref) 4) 169 days (exp), 151 days (ref)
Time to dementia onset includes: 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. Analysis 1-'as-treated' follow-up approach: In this approach, we followed patients from cohort entry until treatment discontinuation or switch to the comparator treatment, insurance disenrollment, death, or administrative endpoint (December 2018). Treatment discontinuation was defined as occurring 90 days after the expected days supply. of the most recently filled prescription to accommodate suboptimal adherence during treatment periods. Analysis 2-'as-started' follow-up approach incorporating a 6-month 'induction' period. Analysis 3-incorporating a 6-month 'symptoms to diagnosis' period Analysis 4-high-specificity outcome definition Study accessed Medicare files (Jan 2008-Dec 2018) between September 1, 2021 to October 4, 2022.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Pulmonary Arterial Hypertension, 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 6 Aug 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?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Median follow up times: 1) 168 days (exp), 151 days (ref) 2) 693 days (exp), 720 days (ref) 3) 382 days (exp), 358 days (ref) 4) 169 days (exp), 151 days (ref)). 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 6 Aug 2025.