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CompletedPhase 4Results posted

Cilostazol Augmentation Study in Dementia

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

Asset

Cilostazol

Listed sites

1

Recruiting sites

-

Enrollment

46

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Regionally Averaged Cerebral Glucose Uptake Changes

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID06-2009-145
NCT IDNCT01409564

Timeline

Milestones

Study start2010-05 (month precision)
Study first posted2011-08-04estimated
Primary completion2012-06actual (month precision)
Study completion2013-07actual (month precision)
Last update posted2014-05-13estimated
Results first posted2014-05-13estimated

Assets

Drug assets

Cilostazol

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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)

Exclusion criteria

•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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
8
Neuroimaging
2
Other (unclassified)
2

Global cognition

8 endpoints
Secondary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)

Time frame:Baseline, 12-week, 24-week

ADAS-Cog

event count, event

Secondary/protocol endpoint

Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)

Time frame:Baseline, 12-month, 24-month

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Activities of Daily Living (ADCS-ADL)

Time frame:Baseline, 12-month, 24-month

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Secondary/protocol endpoint

Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)

Time frame:Baseline, 12-month, 24-month

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Secondary/registry result

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)

Time frame:Baseline, 12-week, 24-week

ADAS-Cog

event count, event

Posted result

GroupValue (mean), units on a scaleStandard deviation
CilostazolBaselinen=18 Participants29.288.79
12-weekn=18 Participants26.336.75
24-weekn=18 Participants25.788.19
PlaceboBaselinen=18 Participants27.787.89
12-weekn=18 Participants24.837.67
24-weekn=18 Participants24.787.41
p0.93Repeated ANOVA

Repeated ANOVA, tested for group\*time interaction effect of ADAS-Cog scores on three data points (Baseline, 12-week, 24-week)

Secondary/registry result

Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)

Time frame:Baseline, 12-month, 24-month

Mini-Mental State Examination (MMSE)

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
CilostazolBaselinen=18 Participants15.113.61
12-weekn=18 Participants16.674.04
24-weekn=18 Participants15.393.94
PlaceboBaselinen=18 Participants15.443.96
12-weekn=18 Participants15.834.84
24-weekn=18 Participants16.224.91
p0.15Repeated ANOVA

Repeated ANOVA, tested for group\*time interaction effect of MMSE scores on three data points (Baseline, 12-week, 24-week)

Secondary/registry result

Activities of Daily Living (ADCS-ADL)

Time frame:Baseline, 12-month, 24-month

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
CilostazolBaselinen=18 Participants50.1711.61
12-weekn=18 Participants48.0013.14
24-weekn=18 Participants46.3315.88
PlaceboBaselinen=18 Participants53.5614.86
12-weekn=18 Participants49.3317.38
24-weekn=18 Participants51.1716.53
p0.82Repeated ANOVA

Repeated ANOVA, tested for group\*time interaction effect of ADCS-ADL scores on three data points (Baseline, 12-week, 24-week)

Secondary/registry result

Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)

Time frame:Baseline, 12-month, 24-month

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
CilostazolBaselinen=18 Participants5.112.30
12-weekn=18 Participants5.422.05
24-weekn=18 Participants5.442.49
PlaceboBaselinen=18 Participants4.721.56
12-weekn=18 Participants5.282.18
24-weekn=18 Participants5.332.88
p0.79Chi-squared

Repeated ANOVA, tested for group\*time interaction effect of Summed CDR scores on three data points (Baseline, 12-week, 24-week)

Neuroimaging

2 endpoints
Primary/protocol endpoint

Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method

Time frame:Baseline, 24-week

ratio, descriptive

Primary/registry result

Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method

Time frame:Baseline, 24-week

ratio, descriptive

Posted result

GroupValue (mean), Bq/Bq (no unit)Standard deviation
Cilostazol, BaselineLeft Parietal Loben=18 Participants81.709.51
Right Parietal Loben=18 Participants80.0310.26
Left Inferior Frontal Gyrusn=18 Participants85.747.03
Right Inferior Frontal Gyrusn=18 Participants72.116.48
Cilostazol, 24-weekLeft Parietal Loben=18 Participants80.408.27
Right Parietal Loben=18 Participants79.009.55
Left Inferior Frontal Gyrusn=18 Participants86.826.06
Right Inferior Frontal Gyrusn=18 Participants71.394.82
Placebo, BaselineLeft Parietal Loben=18 Participants84.607.47
Right Parietal Loben=18 Participants85.298.62
Left Inferior Frontal Gyrusn=18 Participants85.975.72
Right Inferior Frontal Gyrusn=18 Participants74.026.38
Placebo, 24-weekLeft Parietal Loben=18 Participants81.336.82
Right Parietal Loben=18 Participants81.918.37
Left Inferior Frontal Gyrusn=18 Participants83.125.81
Right Inferior Frontal Gyrusn=18 Participants71.445.53
p0.14Repeated ANOVA

Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Parietal Lobe in two groups on two data points (baseline, 24-week).

p0.08Repeated ANOVA

Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Parietal Lobe in two groups on two data points (baseline, 24-week).

p<0.01Repeated ANOVA

Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).

p0.08Repeated ANOVA

Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Fazekas Scale

Time frame:Baseline

descriptive

Secondary/registry result/low confidence

Fazekas Scale

Time frame:Baseline

descriptive

Posted result

GroupValue (number), participantsReported bounds
CilostazolNumber of Patients Scored 1n=18 Participants13-
Number of Patients Scored 2n=18 Participants3-
Number of Patients Scored 3n=18 Participants2-
PlaceboNumber of Patients Scored 1n=18 Participants11-
Number of Patients Scored 2n=18 Participants5-
Number of Patients Scored 3n=18 Participants2-
p0.87Chi-squared

Distribution of Fazekas scale in two groups according to Chi-square test results.

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.