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| Name | Class |
|---|---|
| Korea OIAA | UNKNOWN |
The purpose of this study is to examine the effects of cilostazol augmentation in mild to moderate Alzheimer disease patients with subcortical white matter hyperintensities (WMHI) treated by donepezil.
Dementia is the most disabling disease in the old age. The prevalence of dementia is 5-10% of the elders. AchEIs (donepezil, galantamine, rivastigmine) are used to treat mild to moderate dementia, but these drugs only relate to symptomatic improvement and the response rates are less than 30%.
Cilostazol is a cyclic adenosine monophosphate phosphodiesterase 3 inhibitor (PDE3I) and used as antiplatelet agent in subcortical vascular disease (WMHI). And it upregulates phosphorylation of cyclic adenosine monophosphate-pathway response element binding protein (CREB) which plays a crucial role in memory enhancement and synaptic plasticity related to neurodegeneration prevention.
The investigators will try cilostazol augmentation in dementia patients with WMHI receiving donepezil to see the addictive effects of cilostazol using cognitive tasks and PET imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilostazol | Experimental | Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation. |
|
| Placebo | Placebo Comparator | Placebo group means dementia patients group receiving donepezil with placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | Cilostazol 100mg bid per day will be administered orally and the period is total 24 weeks. The first week is a period for increasing the quantity, and during this period, cilostazol 50mg bid per day will be administered orally. |
| Measure | Description | Time Frame |
|---|---|---|
| Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | 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. | Baseline, 24-week |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) | 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.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Seok Choi, MD, PhD | SMG-SNU Boramae Medical Center, Seoul, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30761509 | Derived | Lee JY, Lee H, Yoo HB, Choi JS, Jung HY, Yoon EJ, Kim H, Jung YH, Lee HY, Kim YK. Efficacy of Cilostazol Administration in Alzheimer's Disease Patients with White Matter Lesions: A Positron-Emission Tomography Study. Neurotherapeutics. 2019 Apr;16(2):394-403. doi: 10.1007/s13311-018-00708-x. |
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46 Subjects were enrolled in the single center of Seoul National University Boramae Hospital. The diagnosis of probable AD was made according to the criteria of NINCDS-ADRDA (MMSE score 10 ~ 26). Enrollment has started in July 2010 to end in March 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cilostazol | Cilostazol group includes dementia patients receiving donepezil with cilostazol augmentation. All the randomly assigned AD patients in cilostazol group received 10 mg of Donepezil along with 200 mg of cilostazol per a day, doubly blinded. All the medications were orally administered. For the initial two weeks, patients only received 100 mg of cilstazol per a day to minimize the instabilities. Afterwards, for 22 weeks, patients received 200 mg of cilostazol. |
| FG001 | Placebo | Placebo group includes dementia patients receiving donepezil with placebo. All the patients were randomly assigned as placebo group and received 10 mg of Donepezil along with the same dose of sugar pill as normal cilostazol. All the clinical assessments and medications were doubly blinded. All the medications were orally administered. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
18 subjects for each group were enrolled in the final list.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cilostazol | Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation. |
| BG001 | Placebo | Placebo group means dementia patients group receiving donepezil with placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method | 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. | 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. | Posted | Mean | Standard Deviation | Bq/Bq (no unit) | Baseline, 24-week |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cilostazol | Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea, Dizziness | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Jung Seok Choi | Seoul National University Hospital | 82-2-870-3461 | choijs@neuroimage.snu.ac.kr |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo with similar shape and color to cilostazol 100mg bid per day will be administered orally and the period is total 24 weeks. The first week is a period for increasing the quantity, and during this period, placebo 50mg bid per day will be administered orally. |
|
| Baseline, 12-week, 24-week |
| Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet) | Basic cognitive functions are checked. (0-30) The score is better when higher. | Baseline, 12-month, 24-month |
| Activities of Daily Living (ADCS-ADL) | 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) | Baseline, 12-month, 24-month |
| Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) | Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms. Score Scale: 0-18 (min-MAX) | Baseline, 12-month, 24-month |
| Fazekas Scale | 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 | Baseline |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation after 24 weeks. |
| OG002 | Placebo, Baseline | Placebo group means dementia patients group receiving donepezil with placebo at the baseline. |
| OG003 | Placebo, 24-week | Placebo group means dementia patients group receiving donepezil with placebo after 24 weeks. |
|
|
|
| Secondary | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) | 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.
| Posted | Mean | Standard Deviation | units on a scale | Baseline, 12-week, 24-week |
|
|
|
|
| Secondary | Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet) | Basic cognitive functions are checked. (0-30) The score is better when higher. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12-month, 24-month |
|
|
|
|
| Secondary | Activities of Daily Living (ADCS-ADL) | 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12-month, 24-month |
|
|
|
|
| Secondary | Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) | Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms. Score Scale: 0-18 (min-MAX) | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12-month, 24-month |
|
|
|
|
| Secondary | Fazekas Scale | 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 | Posted | Number | participants | Baseline |
|
|
|
|
| 0 |
| 18 |
| 4 |
| 18 |
| EG001 | Placebo | Placebo group means dementia patients group receiving donepezil with placebo. | 0 | 18 | 3 | 18 |
| GI discomfort | Gastrointestinal disorders |
|
| Diarrhea | General disorders |
|
| Hypertension | Vascular disorders |
|
| Depression | Psychiatric disorders |
|
| Vomiting | General disorders |
|
| Headache | General disorders |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 24-week |
|
| 24-week |
|
| 24-week |
|
| 24-week |
|
| Number of Patients Scored 3 |
|