Biomarker Study to Diagnose Alzheimer's Disease

Alzheimer Disease Clinical Trial

— ADAM  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01874418
• Other study ID #: ADAM
• Status: Unknown status
• Phase: N/A
• First received: June 3, 2013
• Last updated: June 6, 2013
• Start date: March 2012
• Est. completion date: February 2015

Study information

• Verified date: June 2013
• Source: Seoul National University Hospital
• Contact: Young Ho Park, MD
• Phone: 82-10-6287-8084
• Email: kumimesy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 90
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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:

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University College of Medicine, Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PiB PET	To compare the uptake of PiB PET among normal controls, MCI and AD	baseline
Other	FDG-PET	To compare the pattern of hypometabolism with FDG-PET among normal controls, MCI and AD	baseline
Other	Brain MRI	To compare the volumetry and surface morphometry of brain T1-weighted MRI among normal controls, MCI and AD	baseline
Primary	Oligomeric beta-amyloid 42 in serum	To compare oligomeric beta-amyloid 42 in serum among normal controls, MCI and AD	baseline
Secondary	Total tau concentration in CSF	To compare total tau concentration in CSF among normal controls, MCI and AD	baseline
Secondary	Phosphorylated tau concentration in CSF	To compare phosphorylated tau concentration in CSF among normal controls, MCI and AD	baseline
Secondary	Monomeric beta-amyloid 42 in CSF	To compare monomeric beta-amyloid 42 in CSF among normal controls, MCI and AD	baseline