Trial Outcomes & Findings for Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Pentoxifylline Versus Cilostazol (NCT NCT05635370)
NCT ID: NCT05635370
Last Updated: 2025-08-11
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
10398 participants
Primary outcome timeframe
Median follow up times: 1) 180 days (exp), 170 days (ref) 2) 677 days (exp), 612 days (ref) 3) 211 days (exp), 173 days (ref) 4) 180 days (exp), 171 days (ref)
Results posted on
2025-08-11
Participant Flow
Participant milestones
| Measure |
Pentoxifylline
Exposure group
Pentoxifylline: Pentoxifylline claim is used as the exposure group.
|
Cilostazol
Reference group
Cilostazol: Cilostazol claim is used as the reference group.
|
|---|---|---|
|
Overall Study
STARTED
|
1701
|
8697
|
|
Overall Study
COMPLETED
|
1687
|
1687
|
|
Overall Study
NOT COMPLETED
|
14
|
7010
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Pentoxifylline Versus Cilostazol
Baseline characteristics by cohort
| Measure |
Pentoxifylline
n=1687 Participants
Exposure group
Pentoxifylline: Pentoxifylline claim is used as the exposure group.
|
Cilostazol
n=1687 Participants
Reference group
Cilostazol: Cilostazol claim is used as the reference group.
|
Total
n=3374 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1687 Participants
n=5 Participants
|
1687 Participants
n=7 Participants
|
3374 Participants
n=5 Participants
|
|
Age, Continuous
|
76.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
76.1 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
76.1 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
869 Participants
n=5 Participants
|
848 Participants
n=7 Participants
|
1717 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
818 Participants
n=5 Participants
|
839 Participants
n=7 Participants
|
1657 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1378 Participants
n=5 Participants
|
1390 Participants
n=7 Participants
|
2768 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
156 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
67 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
86 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Dementia risk factors
Anxiety
|
244 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
486 Participants
n=5 Participants
|
|
Dementia risk factors
Bipolar Disorder
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Dementia risk factors
Coronary Artery Disease
|
793 Participants
n=5 Participants
|
767 Participants
n=7 Participants
|
1560 Participants
n=5 Participants
|
|
Dementia risk factors
Depression
|
236 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
479 Participants
n=5 Participants
|
|
Dementia risk factors
Diabetes
|
819 Participants
n=5 Participants
|
807 Participants
n=7 Participants
|
1626 Participants
n=5 Participants
|
|
Dementia risk factors
Hypertension
|
1501 Participants
n=5 Participants
|
1521 Participants
n=7 Participants
|
3022 Participants
n=5 Participants
|
|
Dementia risk factors
Obesity
|
320 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
618 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median follow up times: 1) 180 days (exp), 170 days (ref) 2) 677 days (exp), 612 days (ref) 3) 211 days (exp), 173 days (ref) 4) 180 days (exp), 171 days (ref)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.
Outcome measures
| Measure |
Pentoxifylline
n=1687 Participants
Exposure group
Pentoxifylline: Pentoxifylline claim is used as the exposure group.
|
Cilostazol
n=1687 Participants
Reference group
Cilostazol: Cilostazol claim is used as the reference group.
|
|---|---|---|
|
Time to Dementia Onset
Analysis 1
|
28.1 Incidence rate per 1000 person year
Interval 20.2 to 38.2
|
32.6 Incidence rate per 1000 person year
Interval 23.5 to 44.0
|
|
Time to Dementia Onset
Analysis 2
|
37.9 Incidence rate per 1000 person year
Interval 28.4 to 49.6
|
44.8 Incidence rate per 1000 person year
Interval 34.2 to 57.7
|
|
Time to Dementia Onset
Analysis 3
|
30.8 Incidence rate per 1000 person year
Interval 18.8 to 47.6
|
43.9 Incidence rate per 1000 person year
Interval 28.9 to 63.9
|
|
Time to Dementia Onset
Analysis 4
|
5.2 Incidence rate per 1000 person year
Interval 2.3 to 10.3
|
10.0 Incidence rate per 1000 person year
Interval 5.3 to 17.2
|
Adverse Events
Pentoxifylline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cilostazol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER