Biomarker Study to Diagnose Alzheimer's Disease

NCT ID: NCT01874418

Last Updated: 2013-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-02-28

Brief Summary

The purpose of our study is to investigate CSF and blood biomarkers among the subjects with mild cognitive impairment (MCI) and Alzheimer's disease (AD) as well as normal controls.

Detailed Description

Alzheimer's disease is the most prevalent cause of dementia. A biomarker is a variable that are measured in vivo and indicate specific features of disease related molecular mechanisms and pathologic changes, including amyloid processing and aggregation, tau hyperphosphorylation, accumulation of neurofibrillary tangles, synaptic dysfunction, neurodegeneration, and loss of brain tissue.

We examine serum oligomeric beta-amyloid 42 and CSF monomeric beta-amyloid 42, total tau and phosphorylated tau, as well as PiB-PET, FDG-PET and brain MRI in 90 participants (30 normal controls, 30 patients with mild cognitive impairment, 30 patients with Alzheimer's disease).

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Biomarker study

Oligomeric beta-amyloid 42 in serum, as well as, monomeric beta-amyloid 42, total tau and phosphorylated tau in CSF

Group Type: OTHER

Biomarker

Intervention Type: OTHER

Oligomeric beta-amyloid 42 in serum, as well as, monomeric beta-amyloid 42, total tau and phosphorylated tau in CSF

Interventions

Biomarker

Oligomeric beta-amyloid 42 in serum, as well as, monomeric beta-amyloid 42, total tau and phosphorylated tau in CSF

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Signed and dated written informed consent obtained from the subject or the subject's legally acceptable representative ( if applicable) in accordance with the local regularities.

2. Both male and female, aged > 50 and <90, if women, must have no childbearing potential

3. Controls did not have subjective memory complaints or any of 28 diseases and did not have a history suggestive of a decrease in cognitive function (stroke or transient ischemic attack, seizures, Parkinson's disease, multiple sclerosis, cerebral palsy, Huntington's disease, encephalitis, meningitis, brain surgery, vascular surgery of the brain, diabetes requiring insulin control, improperly managed hypertension, cancer diagnosed within the past 3 years excluding skin cancer, shortness of breath while sitting still, use of home oxygen, heart attack with changes in memory, walking, or solving problems lasting at least 24 hours afterwards, kidney dialysis, liver disease, hospitalization for mental or emotional problems in the past 5 years, current use of medications for mental or emotional problems, alcohol consumption greater than 3 drinks each day, drug abuse in the past 5 years, treatment for alcohol abuse in the past 5 years, unconsciousness for more than one hour other than during surgery, overnight hospitalization due to head injury, illness causing a permanent decrease in memory or other mental functions, trouble with vision that prevents reading ordinary print even with glasses, or difficulty understanding conversations because of hearing even with a hearing aid)

4. The controls also had scores that were at least one standard deviation above the mean scores of the respective age- and education-matched population on the K-MMSE and an average score of 0.42 or less on the Korean Instrumental Activities of Daily Living (K-IADL)

Exclusion Criteria

-

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

SangYun Kim

Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University College of Medicine, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Young Ho Park, MD

Role: CONTACT

kumimesy@gmail.com

82-10-6287-8084

SangYun Kim, MD, PhD

Role: CONTACT

neuroksy@snu.ac.kr

82-31-787-7462

Facility Contacts

Young Ho Park, MD

Role: primary

kumimesy@gmail.com

82-10-6287-8084

Other Identifiers

ADAM

Identifier Type: -

Identifier Source: org_study_id