NCT01874418

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

2.9 years

First QC Date

June 3, 2013

Last Update Submit

June 6, 2013

Conditions

Alzheimer DiseaseMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Oligomeric beta-amyloid 42 in serum

    To compare oligomeric beta-amyloid 42 in serum among normal controls, MCI and AD

    baseline

Secondary Outcomes (3)

  • Total tau concentration in CSF

    baseline

  • Phosphorylated tau concentration in CSF

    baseline

  • Monomeric beta-amyloid 42 in CSF

    baseline

Other Outcomes (3)

  • PiB PET

    baseline

  • FDG-PET

    baseline

  • Brain MRI

    baseline

Study Arms (1)

Biomarker study

OTHER

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

Other: Biomarker

Interventions

BiomarkerOTHER

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

Biomarker study

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Biological Factors

Central Study Contacts

Young Ho Park, MD

CONTACT

82-10-6287-8084kumimesy@gmail.com

SangYun Kim, MD, PhD

CONTACT

82-31-787-7462neuroksy@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 11, 2013

Study Start

March 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

KR(1)