Trial · NCT01409564
Cilostazol Augmentation Study in Dementia
NCT01409564, Phase 4, Completed, Seoul National University Hospital; results first posted 2014-05-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cilostazol Augmentation Study in Dementia. Trials, record NCT01409564. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01409564
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cilostazol Augmentation Study in Dementia
- NCT number
- NCT01409564
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 46 participants, actual
- Lead sponsor
- Seoul National University Hospital
- Conditions
- Alzheimer's Dementia
- Interventions
- Cilostazol, Placebo
- First posted
- 2011-08-04
- Last updated
- 2014-05-13
- Results first posted
- 2014-05-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Baseline, 24-week | Regional cerebral glucose uptake level was measured as the ratio value of FDG uptake of the each unit level to the global mean uptake value. |
| Secondary | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) | Baseline, 12-week, 24-week | The ADAS-Cog score is measured by the number of questions answered incorrectly, therefore the higher is the worse. Score Scale: 0-75 (min-MAX) Each subcategory scores are summed. 1. Word-recall test (0-10) 2. Commands (0-5) 3. Constructional praxis (0-5) 4. Naming Objects/ Fingers (0-5) 5. Ideational Praxis (0-5) 6. Orientation (0-8) 7. Word Recognition (0-12) 8. Remembering Test Instructions (0-5) 9. Spoken Language Ability (0-5) 10. Word Finding Difficulty (0-5) 11. Comprehension (0-5) |
| Secondary | Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet) | Baseline, 12-month, 24-month | Basic cognitive functions are checked. (0-30) The score is better when higher. |
| Secondary | Activities of Daily Living (ADCS-ADL) | Baseline, 12-month, 24-month | The caregiver answered to the questions given to measure the cognitive function level of the patients in daily living. Lower scores indicate greater severity. 23 questions Score Scale: 0-78 (min-MAX) |
| Secondary | Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) | Baseline, 12-month, 24-month | Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms. Score Scale: 0-18 (min-MAX) |
| Secondary | Fazekas Scale | Baseline | Level of severity of white matter lesions in AD patients who can be legitimately administered with cilostazol. Measured by professionally trained clinicians. The higher score indicates more severe white matter lesion. Max-min: 0-3 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Baseline, 24-week | Number of patients with increased whole brain glucose uptake level. In the real analysis, however, a voxel-based image analysis results were used; therefore, data which can be entered here is not much meaningful. | Bq/Bq (no unit) | MEAN |
| SECONDARY | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) | Baseline, 12-week, 24-week | units on a scale | MEAN | |
| SECONDARY | Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet) | Baseline, 12-month, 24-month | units on a scale | MEAN | |
| SECONDARY | Activities of Daily Living (ADCS-ADL) | Baseline, 12-month, 24-month | units on a scale | MEAN | |
| SECONDARY | Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) | Baseline, 12-month, 24-month | units on a scale | MEAN | |
| SECONDARY | Fazekas Scale | Baseline | participants | NUMBER |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Cilostazol, Baseline | Left Parietal Lobe | 81.70 | Standard Deviation 9.51 | Bq/Bq (no unit) |
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Cilostazol, 24-week | Left Parietal Lobe | 80.40 | Standard Deviation 8.27 | Bq/Bq (no unit) |
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Placebo, Baseline | Left Parietal Lobe | 84.60 | Standard Deviation 7.47 | Bq/Bq (no unit) |
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Placebo, 24-week | Left Parietal Lobe | 81.33 | Standard Deviation 6.82 | Bq/Bq (no unit) |
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Cilostazol, Baseline | Right Parietal Lobe | 80.03 | Standard Deviation 10.26 | Bq/Bq (no unit) |
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Cilostazol, 24-week | Right Parietal Lobe | 79.00 | Standard Deviation 9.55 | Bq/Bq (no unit) |
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Placebo, Baseline | Right Parietal Lobe | 85.29 | Standard Deviation 8.62 | Bq/Bq (no unit) |
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Placebo, 24-week | Right Parietal Lobe | 81.91 | Standard Deviation 8.37 | Bq/Bq (no unit) |
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Cilostazol, Baseline | Left Inferior Frontal Gyrus | 85.74 | Standard Deviation 7.03 | Bq/Bq (no unit) |
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | Cilostazol, 24-week | Left Inferior Frontal Gyrus | 86.82 | Standard Deviation 6.06 | Bq/Bq (no unit) |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cilostazol | 23 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | COMPLETED | Cilostazol | 18 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Cilostazol | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea, Dizziness | General disorders | Cilostazol | 1 | 18 | 1 |
| other | Nausea, Dizziness | General disorders | Placebo | 0 | 18 | 0 |
| other | GI discomfort | Gastrointestinal disorders | Cilostazol | 1 | 18 | 1 |
| other | GI discomfort | Gastrointestinal disorders | Placebo | 0 | 18 | 0 |
| other | Diarrhea | General disorders | Cilostazol | 1 | 18 | 1 |
| other | Diarrhea | General disorders | Placebo | 0 | 18 | 0 |
| other | Hypertension | Vascular disorders | Cilostazol | 1 | 18 | 1 |
| other | Hypertension | Vascular disorders | Placebo | 0 | 18 | 0 |
| other | Depression | Psychiatric disorders | Cilostazol | 0 | 18 | 0 |
| other | Depression | Psychiatric disorders | Placebo | 1 | 18 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilostazol | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Cilostazol | 4 | 18 |
| Total, other adverse events | Placebo | 3 | 18 |
| Total, serious adverse events | Cilostazol | 0 | 18 |
| Total, serious adverse events | Placebo | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30761509 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cilostazol vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01409564
GET https://conductscience.org/api/trials/v1/NCT01409564/results?page=2