Cilostazol Augmentation Study in Dementia

NCT01409564 | Completed Phase 4 Results

• 1 other identifier: 06-2009-145
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer's Dementia

Keywords

Alzheimer's dementia; Cilostazol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

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

  Baseline, 12-week, 24-week

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

  Baseline, 12-month, 24-month

• Activities of Daily Living (ADCS-ADL)

  Baseline, 12-month, 24-month

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

  Baseline, 12-month, 24-month

• Fazekas Scale

  Baseline

Study Arms (2)

Cilostazol

EXPERIMENTAL

Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.

Drug: Cilostazol

Placebo

PLACEBO COMPARATOR

Placebo group means dementia patients group receiving donepezil with placebo.

Drug: Placebo

Interventions

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.

Cilostazol

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.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korea OIAA: collaborator

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 30761509 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Prof. Jung Seok Choi
• Organization: Seoul National University Hospital

choijs@neuroimage.snu.ac.kr

82-2-870-3461

Study Officials

• Jung-Seok Choi, MD, PhD

  SMG-SNU Boramae Medical Center, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 4, 2011
• Study Start: May 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2013
• Last Updated: May 13, 2014
• Results First Posted: May 13, 2014

Record last verified: 2014-04

Locations

KR (1)