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Biomarker Study to Diagnose Alzheimer's Disease

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01874418
Acronym
ADAM
Enrollment
90
Registered
2013-06-11
Start date
2012-03-31
Completion date
2015-02-28
Last updated
2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Mild Cognitive Impairment

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).

Interventions

OTHERBiomarker

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Oligomeric beta-amyloid 42 in serumbaselineTo compare oligomeric beta-amyloid 42 in serum among normal controls, MCI and AD

Secondary

MeasureTime frameDescription
Total tau concentration in CSFbaselineTo compare total tau concentration in CSF among normal controls, MCI and AD
Phosphorylated tau concentration in CSFbaselineTo compare phosphorylated tau concentration in CSF among normal controls, MCI and AD
Monomeric beta-amyloid 42 in CSFbaselineTo compare monomeric beta-amyloid 42 in CSF among normal controls, MCI and AD

Other

MeasureTime frameDescription
FDG-PETbaselineTo compare the pattern of hypometabolism with FDG-PET among normal controls, MCI and AD
Brain MRIbaselineTo compare the volumetry and surface morphometry of brain T1-weighted MRI among normal controls, MCI and AD
PiB PETbaselineTo compare the uptake of PiB PET among normal controls, MCI and AD

Countries

South Korea

Contacts

Primary ContactYoung Ho Park, MD
kumimesy@gmail.com82-10-6287-8084
Backup ContactSangYun Kim, MD, PhD
neuroksy@snu.ac.kr82-31-787-7462

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026