Biomarker Study to Diagnose Alzheimer's Disease (ADAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
SangYun Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01874418
First received: June 3, 2013
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Alzheimer Disease
Mild Cognitive Impairment
Other: Biomarker

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study for Usefulness and Standardization of CSF and Blood Biomarkers in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Oligomeric beta-amyloid 42 in serum [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To compare oligomeric beta-amyloid 42 in serum among normal controls, MCI and AD


Secondary Outcome Measures:
  • Total tau concentration in CSF [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To compare total tau concentration in CSF among normal controls, MCI and AD

  • Phosphorylated tau concentration in CSF [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To compare phosphorylated tau concentration in CSF among normal controls, MCI and AD

  • Monomeric beta-amyloid 42 in CSF [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To compare monomeric beta-amyloid 42 in CSF among normal controls, MCI and AD


Other Outcome Measures:
  • PiB PET [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To compare the uptake of PiB PET among normal controls, MCI and AD

  • FDG-PET [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To compare the pattern of hypometabolism with FDG-PET among normal controls, MCI and AD

  • Brain MRI [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To compare the volumetry and surface morphometry of brain T1-weighted MRI among normal controls, MCI and AD


Estimated Enrollment: 90
Study Start Date: March 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Biomarker study
Oligomeric beta-amyloid 42 in serum, as well as, monomeric beta-amyloid 42, total tau and phosphorylated tau in CSF
Other: Biomarker
Oligomeric beta-amyloid 42 in serum, as well as, monomeric beta-amyloid 42, total tau and phosphorylated tau in CSF

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).

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874418

Contacts
Contact: Young Ho Park, MD 82-10-6287-8084 kumimesy@gmail.com
Contact: SangYun Kim, MD, PhD 82-31-787-7462 neuroksy@snu.ac.kr

Locations
Korea, Republic of
Seoul National University College of Medicine, Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Young Ho Park, MD    82-10-6287-8084    kumimesy@gmail.com   
Sub-Investigator: Youg Ho Park, MD         
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: SangYun Kim, Department of Neurology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01874418     History of Changes
Other Study ID Numbers: ADAM
Study First Received: June 3, 2013
Last Updated: June 6, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014