Cilostazol Augmentation Study in Dementia

NCT ID: NCT01409564

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cilostazol

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

Group Type: EXPERIMENTAL

Cilostazol

Intervention Type: 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.

Placebo

Placebo group means dementia patients group receiving donepezil with placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Cilostazol

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea OIAA

UNKNOWN

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jung-Seok Choi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jung-Seok Choi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30761509 (View on PubMed)

Other Identifiers

06-2009-145

Identifier Type: -

Identifier Source: org_study_id