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Trial Outcomes & Findings for Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5 (NCT NCT05039086)

NCT ID: NCT05039086

Last Updated: 2025-08-06

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

13021 participants

Primary outcome timeframe

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)

Results posted on

2025-08-06

Participant Flow

Participant milestones

Participant milestones
Measure
PDE5 Inhibitors
Exposure group PDE5 inhibitor: PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.
Endothelin Receptor Antagonists
Reference group Endothelin Receptor Antagonists: Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.
Overall Study
STARTED
9968
3053
Overall Study
COMPLETED
2888
2888
Overall Study
NOT COMPLETED
7080
165

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PDE5 Inhibitors
n=2888 Participants
Exposure group PDE5 inhibitor: PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.
Endothelin Receptor Antagonists
n=2888 Participants
Reference group Endothelin Receptor Antagonists: Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.
Total
n=5776 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
>=65 years
2888 Participants
n=93 Participants
2888 Participants
n=4 Participants
5776 Participants
n=27 Participants
Age, Continuous
73.87 years
STANDARD_DEVIATION 6.43 • n=93 Participants
73.84 years
STANDARD_DEVIATION 6.15 • n=4 Participants
73.86 years
STANDARD_DEVIATION 6.65 • n=27 Participants
Sex: Female, Male
Female
1999 Participants
n=93 Participants
1990 Participants
n=4 Participants
3989 Participants
n=27 Participants
Sex: Female, Male
Male
889 Participants
n=93 Participants
898 Participants
n=4 Participants
1787 Participants
n=27 Participants
Race/Ethnicity, Customized
White
2293 Participants
n=93 Participants
2311 Participants
n=4 Participants
4604 Participants
n=27 Participants
Race/Ethnicity, Customized
Black
421 Participants
n=93 Participants
411 Participants
n=4 Participants
832 Participants
n=27 Participants
Race/Ethnicity, Customized
Asian
51 Participants
n=93 Participants
53 Participants
n=4 Participants
104 Participants
n=27 Participants
Race/Ethnicity, Customized
Hispanic
48 Participants
n=93 Participants
46 Participants
n=4 Participants
94 Participants
n=27 Participants
Race/Ethnicity, Customized
Native American
11 Participants
n=93 Participants
11 Participants
n=4 Participants
22 Participants
n=27 Participants
Race/Ethnicity, Customized
Other
49 Participants
n=93 Participants
41 Participants
n=4 Participants
90 Participants
n=27 Participants
Race/Ethnicity, Customized
Unknown
15 Participants
n=93 Participants
15 Participants
n=4 Participants
30 Participants
n=27 Participants
Dementia risk factors
Diabetes
1180 Participants
n=93 Participants
1145 Participants
n=4 Participants
2325 Participants
n=27 Participants
Dementia risk factors
Obesity
911 Participants
n=93 Participants
918 Participants
n=4 Participants
1829 Participants
n=27 Participants
Dementia risk factors
Hypertension
2587 Participants
n=93 Participants
2595 Participants
n=4 Participants
5182 Participants
n=27 Participants
Dementia risk factors
Coronary artery disease
2136 Participants
n=93 Participants
2150 Participants
n=4 Participants
4286 Participants
n=27 Participants
Dementia risk factors
Depression
515 Participants
n=93 Participants
537 Participants
n=4 Participants
1052 Participants
n=27 Participants
Dementia risk factors
Anxiety
466 Participants
n=93 Participants
465 Participants
n=4 Participants
931 Participants
n=27 Participants
Dementia risk factors
Bipolar disorder
28 Participants
n=93 Participants
32 Participants
n=4 Participants
60 Participants
n=27 Participants
Dementia risk factors
Schizophrenia
12 Participants
n=93 Participants
12 Participants
n=4 Participants
24 Participants
n=27 Participants

PRIMARY outcome

Timeframe: 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)

Population: Study cohort after 1:1 propensity score matching

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.

Outcome measures

Outcome measures
Measure
PDE5 Inhibitors
n=2888 Participants
Exposure group PDE5 inhibitor: PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.
Endothelin Receptor Antagonists
n=2888 Participants
Reference group Endothelin Receptor Antagonists: Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.
Time to Dementia Onset
Analysis 2
19.8 Incidence rate per 1000 person year
Interval 15.2 to 25.4
19.9 Incidence rate per 1000 person year
Interval 15.3 to 25.4
Time to Dementia Onset
Analysis 1
17.9 Incidence rate per 1000 person year
Interval 13.5 to 23.4
18.8 Incidence rate per 1000 person year
Interval 14.3 to 24.3
Time to Dementia Onset
Analysis 3
15.1 Incidence rate per 1000 person year
Interval 10.2 to 21.4
22.6 Incidence rate per 1000 person year
Interval 16.5 to 30.1
Time to Dementia Onset
Analysis 4
5.2 Incidence rate per 1000 person year
Interval 3.0 to 8.4
4.7 Incidence rate per 1000 person year
Interval 2.7 to 7.8

Adverse Events

PDE5 Inhibitors

Serious events: 0 serious events
Other events: 0 other events
Deaths: 327 deaths

Endothelin Receptor Antagonists

Serious events: 0 serious events
Other events: 0 other events
Deaths: 407 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rishi J Desai, PhD

Brigham and Women's Hospital

Phone: 617-278-0932

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place