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Clinical Cohort of Memory Disorders

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This observational study is designed as a multicenter clinical cohort to collect and bank blood specimens linked to clinical and brain imaging data for biomarker discovery and validation in memory disorders. The protocol lists Severance Hospital, Gangnam Severance Hospital, and Yongin Severance Hospital as study sites. Planned enrollment is 1,550 participants: 1,500 adults aged 50 years or older and 50 healthy young adult controls aged 19-30 years. Participants are enrolled according to eligibility criteria and consent, irrespective of the specific medication received. Clinical information, cognitive assessments, and available brain magnetic resonance imaging (MRI) and positron emission tomography (PET) data will be collected to investigate diagnosis, disease severity, and clinical course. A total of 6 mL of research blood will be collected for banking, separated into plasma and buffy coat, and stored at -70°C. Young adult controls will provide a comparison for age-related and disease-related biomarker differences. The target follow-up duration for the memory disorder cohort is 5 years; young adult controls attend a single study visit. The overall study period is 120 months from IRB approval.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

⁃ Healthy young adult controls: Adults of either sex aged 19-30 years. Participants must consent to participation. For patients with limited consent capacity and MMSE \<15, additional consent from a family representative is obtained.

⁃ Exclusuion Criteria Memory disorder cohort: Uncontrolled acute or chronic infection, or another life-threatening systemic illness.

⁃ Healthy young adult controls:

• Any current self-reported medical, surgical, neurological, or psychiatric condition.

• Self-reported history of liver, kidney, or heart disease.

• Daily medication use.

• Alcohol consumption on the day before blood collection.

• Severe impact to the head within the past year, including a motor vehicle accident or fall.

• Loss of consciousness for any reason within the past year.

Locations
Other Locations
Republic of Korea
Yonsei University College of Medicine
RECRUITING
Seoul
Contact Information
Primary
Eosu Kim, Professor
KIMEOSU@yuhs.ac
+82-2-2228-1620
Time Frame
Start Date: 2020-09-10
Estimated Completion Date: 2030-09-09
Participants
Target number of participants: 1550
Treatments
Memory disorder cohort
dults aged 50 years or older recruited at the three participating hospitals. The study focuses on the spectrum of memory disorders, including subjective memory impairment, mild cognitive impairment, and dementia. Blood specimens are linked to clinical data and available cognitive and neuroimaging assessments. Participants receiving anti-amyloid antibody treatment form a subgroup with repeated blood sampling before treatment, before the 5th, 7th, 14th, and 26th administrations, at week 72 or treatment termination, and when amyloid-related imaging abnormalities are suspected. Target enrollment: 1,500.
Healthy young adult controls
Healthy adults aged 19-30 years recruited through university notice boards and online advertisements. Participants attend one visit for memory screening and blood collection, including hematology, clinical chemistry, and APOE genotyping. Demographic information, height, weight, Mini-Mental State Examination, Clinical Dementia Rating, and Global Deterioration Scale are collected. Target enrollment: 50 (25 men and 25 women) at Severance Hospital.
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov