Alzheimer's DementiaPhase 4NCT01409564
Cilostazol Augmentation Study in Dementia
A Phase 4 study testing Cilostazol in people with Alzheimer's Dementia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Dementia
- What is being tested?
- Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to Jul 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men/women over sixty years old
- Patients with slight and moderate dementia (MMSE score is over 10 under 26.)
- Patients with probable Alzheimer's disease according to the standard of NINCDS-ADRDA
- Patients accompanied with WMHI on Brain MRI (Fazeka's scale 1~3)
Who cannot join
- Those who do not agree to the test in a written form
- Patients who accompany other diseases except cerebral atrophy or change of subcortical white matter due to Alzheimer's disease on brain MRI
- Patients who should not use Cilostazol (① patients with bleeding tendency ② patients with congestive heart failure ③ patients who have a medical history of hypersensitivity to this medicine or constituent of this medicine ④ those who use anticoagulant and clot buster)
- Patients who suffer from nerve diseases or mental diseases which have influence on cognitive function except Alzheimer's disease (for example, schizophrenia, severe depression, mental retardation and etc.)
- Patients who are suspected to have a personal history of drug addiction or alcoholism within recent 10 years
- Patients who have severe problems in eye sight or hearing so that it is impossible to conduct the test smoothly
- Patients who the researchers think are inappropriate for taking part in the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cilostazol Augmentation Study In Dementia (CASID): A Randomized, Placebo-controlled Pilot Study to Compare the Efficacy Between Donepezil Monotherapy and Cilostazol Augmentation Therapy in Alzheimer's Disease Patients With Subcortical White Matter Hyperintensities
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%.
Read more
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.
- Conditions
- Alzheimer's Dementia
- Being tested
- Cilostazol, Placebo
- Keywords
- Alzheimer's dementia, Cilostazol
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol | Experimental | Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation. Receives: Drug: Cilostazol |
| Placebo | Placebo comparator | Placebo group means dementia patients group receiving donepezil with placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 24-week
Secondary outcomes (5)
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.
- Word-recall test (0-10)
- Commands (0-5)
- Constructional praxis (0-5)
- Naming Objects/ Fingers (0-5)
- Ideational Praxis (0-5)
- Orientation (0-8)
- Word Recognition (0-12)
- Remembering Test Instructions (0-5)
- Spoken Language Ability (0-5)
- Word Finding Difficulty (0-5)
- Comprehension (0-5)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DementiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea OIAA
- Responsible party
- Principal investigator, Jung-Seok Choi, Seoul National University Hospital
- Investigators
- Jung-Seok Choi, MD, PhD, Principal investigator, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409564
- Sponsor's protocol ID
- 06-2009-145
- Status last verified
- Apr 2014
- First submitted
- 3 Aug 2011
- Last updated
- 13 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 30761509
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cilostazol Augmentation Study In Dementia (CASID): A Randomized, Placebo-controlled Pilot Study to Compare the Efficacy Between Donepezil Monotherapy and Cilostazol Augmentation Therapy in Alzheimer's Disease Patients With Subcortical White Matter Hyperintensities
- ClinicalTrials.gov ID
- NCT01409564
- Acronym / sponsor ID
- 06-2009-145
- Conditions
- Alzheimer's Dementia
- Keywords
- Alzheimer's dementia, Cilostazol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea OIAA
- Study start
- May 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Posted 13 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol | Experimental | Drug: CilostazolCilostazol group means dementia patients group receiving donepezil with cilostazol augmentation. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group means dementia patients group receiving donepezil with placebo. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men/women over sixty years old
- Patients with slight and moderate dementia (MMSE score is over 10 under 26.)
- Patients with probable Alzheimer's disease according to the standard of NINCDS-ADRDA
- Patients accompanied with WMHI on Brain MRI (Fazeka's scale 1~3)
Key exclusion criteria (7 listed)
- Those who do not agree to the test in a written form
- Patients who accompany other diseases except cerebral atrophy or change of subcortical white matter due to Alzheimer's disease on brain MRI
- Patients who should not use Cilostazol (① patients with bleeding tendency ② patients with congestive heart failure ③ patients who have a medical history of hypersensitivity to this medicine or constituent of this medicine ④ those who use anticoagulant and clot buster)
- Patients who suffer from nerve diseases or mental diseases which have influence on cognitive function except Alzheimer's disease (for example, schizophrenia, severe depression, mental retardation and etc.)
- Patients who are suspected to have a personal history of drug addiction or alcoholism within recent 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CilostazolCilostazol 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. | Drug | Cilostazol |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method
Time frame: 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.
5 secondary outcomes
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)
Time frame: Baseline, 12-week, 24-week
Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)
Time frame: Baseline, 12-month, 24-month
Activities of Daily Living (ADCS-ADL)
Time frame: Baseline, 12-month, 24-month
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time frame: Baseline, 12-month, 24-month
Fazekas Scale
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30761509Lee 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Seok Choi, MD, PhD principal investigator
SMG-SNU Boramae Medical Center, Seoul, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cilostazol in people with Alzheimer's Dementia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method (time frame: Baseline, 24-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01409564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.