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Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5 Inhibitors vs Endothelin Receptor Antagonist

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05039086
Recruitment Status : Active, not recruiting
First Posted : September 9, 2021
Last Update Posted : November 23, 2021
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Rutgers University
Johns Hopkins University
Information provided by (Responsible Party):
Rishi J. Desai, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Drug: PDE5 inhibitor Drug: Endothelin Receptor Antagonists

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.

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Study Type : Observational
Actual Enrollment : 12947 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- PDE5 Inhibitors vs Endothelin Receptor Antagonist
Actual Study Start Date : September 1, 2021
Actual Primary Completion Date : September 30, 2021
Estimated Study Completion Date : January 30, 2023


Group/Cohort Intervention/treatment
PDE5 inhibitors
Exposure group
Drug: PDE5 inhibitor
PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.

Endothelin receptor antagonists
Reference group
Drug: Endothelin Receptor Antagonists
Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.




Primary Outcome Measures :
  1. Time to dementia onset [ Time Frame: Through study completion (a median of 242 days) ]
    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 Outcome Measures :
  1. Time to Alzheimer's disease onset [ Time Frame: Through study completion (a median of 242 days) ]
    Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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).
Criteria

Please see https://docs.google.com/spreadsheets/d/19NwmDi8xwWjzXqhSLPDTg4CKHt5UDQXuwCnZwY8jCS8/edit?usp=sharing or Appendix A 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. 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05039086


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute on Aging (NIA)
Rutgers University
Johns Hopkins University
Investigators
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Principal Investigator: Madhav Thambisetty, MD, PhD National Institute on Aging (NIA)
  Study Documents (Full-Text)

Documents provided by Rishi J. Desai, Brigham and Women's Hospital:
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Responsible Party: Rishi J. Desai, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT05039086    
Other Study ID Numbers: 2019A010961-8
First Posted: September 9, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Phosphodiesterase 5 Inhibitors
Endothelin Receptor Antagonists
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action