Biomarker Study to Diagnose Alzheimer's Disease (ADAM)
Primary Purpose
Alzheimer Disease, Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Biomarker
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
-
Sites / Locations
- Seoul National University College of Medicine, Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Biomarker study
Arm Description
Oligomeric beta-amyloid 42 in serum, as well as, monomeric beta-amyloid 42, total tau and phosphorylated tau in CSF
Outcomes
Primary Outcome Measures
Oligomeric beta-amyloid 42 in serum
To compare oligomeric beta-amyloid 42 in serum among normal controls, MCI and AD
Secondary Outcome Measures
Total tau concentration in CSF
To compare total tau concentration in CSF among normal controls, MCI and AD
Phosphorylated tau concentration in CSF
To compare phosphorylated tau concentration in CSF among normal controls, MCI and AD
Monomeric beta-amyloid 42 in CSF
To compare monomeric beta-amyloid 42 in CSF among normal controls, MCI and AD
Full Information
NCT ID
NCT01874418
First Posted
June 3, 2013
Last Updated
June 6, 2013
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01874418
Brief Title
Biomarker Study to Diagnose Alzheimer's Disease
Acronym
ADAM
Official Title
Study for Usefulness and Standardization of CSF and Blood Biomarkers in Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mild Cognitive Impairment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biomarker study
Arm Type
Other
Arm Description
Oligomeric beta-amyloid 42 in serum, as well as, monomeric beta-amyloid 42, total tau and phosphorylated tau in CSF
Intervention Type
Other
Intervention Name(s)
Biomarker
Intervention Description
Oligomeric beta-amyloid 42 in serum, as well as, monomeric beta-amyloid 42, total tau and phosphorylated tau in CSF
Primary Outcome Measure Information:
Title
Oligomeric beta-amyloid 42 in serum
Description
To compare oligomeric beta-amyloid 42 in serum among normal controls, MCI and AD
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Total tau concentration in CSF
Description
To compare total tau concentration in CSF among normal controls, MCI and AD
Time Frame
baseline
Title
Phosphorylated tau concentration in CSF
Description
To compare phosphorylated tau concentration in CSF among normal controls, MCI and AD
Time Frame
baseline
Title
Monomeric beta-amyloid 42 in CSF
Description
To compare monomeric beta-amyloid 42 in CSF among normal controls, MCI and AD
Time Frame
baseline
Other Pre-specified Outcome Measures:
Title
PiB PET
Description
To compare the uptake of PiB PET among normal controls, MCI and AD
Time Frame
baseline
Title
FDG-PET
Description
To compare the pattern of hypometabolism with FDG-PET among normal controls, MCI and AD
Time Frame
baseline
Title
Brain MRI
Description
To compare the volumetry and surface morphometry of brain T1-weighted MRI among normal controls, MCI and AD
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Ho Park, MD
Phone
82-10-6287-8084
Email
kumimesy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
SangYun Kim, MD, PhD
Phone
82-31-787-7462
Email
neuroksy@snu.ac.kr
Facility Information:
Facility Name
Seoul National University College of Medicine, Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Ho Park, MD
Phone
82-10-6287-8084
Email
kumimesy@gmail.com
First Name & Middle Initial & Last Name & Degree
Youg Ho Park, MD
12. IPD Sharing Statement
Learn more about this trial
Biomarker Study to Diagnose Alzheimer's Disease
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