Biomarker Study to Diagnose Alzheimer's Disease (ADAM)

Study for Usefulness and Standardization of CSF and Blood Biomarkers in Alzheimer's Disease

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Other: Biomarker

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).

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Ho Park, MD; Phone Number: 82-10-6287-8084; Email: kumimesy@gmail.com
• Study Contact Backup: Name: SangYun Kim, MD, PhD; Phone Number: 82-31-787-7462; Email: neuroksy@snu.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University College of Medicine, Seoul National University Bundang Hospital
      • Contact: Young Ho Park, MD; Phone Number: 82-10-6287-8084; Email: kumimesy@gmail.com
      • Sub-Investigator: Youg Ho Park, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oligomeric beta-amyloid 42 in serum	To compare oligomeric beta-amyloid 42 in serum among normal controls, MCI and AD	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total tau concentration in CSF	To compare total tau concentration in CSF among normal controls, MCI and AD	baseline
Phosphorylated tau concentration in CSF	To compare phosphorylated tau concentration in CSF among normal controls, MCI and AD	baseline
Monomeric beta-amyloid 42 in CSF	To compare monomeric beta-amyloid 42 in CSF among normal controls, MCI and AD	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PiB PET	To compare the uptake of PiB PET among normal controls, MCI and AD	baseline
FDG-PET	To compare the pattern of hypometabolism with FDG-PET among normal controls, MCI and AD	baseline
Brain MRI	To compare the volumetry and surface morphometry of brain T1-weighted MRI among normal controls, MCI and AD	baseline

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: June 3, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 11, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: ADAM