NCT02137460

Brief Summary

This is a prospective cohort study for cognitively normal (young and old), mild cognitive impairment, and Alzheimer's disease people

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
721

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

8.6 years

First QC Date

May 8, 2014

Last Update Submit

May 2, 2024

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Keywords

Alzheimer's diseaseEarly diagnosisPredictionBiomarkerImaging

Outcome Measures

Primary Outcomes (1)

  • The amount of brain amyloid deposition

    Group difference in baseline brain amyloid deposition (on PIB PET) and the relationship between the amount of brain amyloid deposition and clinical, neuropsychological, neuroimaging, genetic, biochemical measurement will be investigated.

    baseline

Secondary Outcomes (6)

  • Group difference for each clinical, neuropsychological, structural and functional neuroimaging, tau imaging, genetic, biochemical measures

    baseline

  • Change of brain amyloid deposition

    baseline, 2yr, 4yr

  • Change of clinical, neuropsychological measures

    baseline, 1yr, 2yr,3yr, 4yr

  • Change of structural and functional neuroimaging measures

    baseline, 2yr, 4yr

  • Change of biochemical measures

    baseline, 2yr, 4yr

  • +1 more secondary outcomes

Study Arms (4)

Young normal controls

* age : 20 \~ 55 * without dementia, MCI, or other major neurological/psychiatric illness

Elderly normal controls

* age : 55 \~ 90 * without dementia, MCI, or other major neurological/psychiatric illness

MCI (Mild cognitive impairment)

* age : 55 \~ 90 * without major neurological/psychiatric illness * concern regarding a change in cognition, lower performance in episodic memory domains that is greater than would be expected for the subject's age and educational background and preservation of independence in functional abilities

AD (Alzheimer's diseases)

* age: 55 \~ 90 * National Institute of Aging and the Alzheimer's Association (NIA-AA) Probable AD dementia

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Young and elderly normal controls: community-based population AD and MCI: clinic or community-based population

You may qualify if:

  • Age : 55 - 90
  • Clinical Dementia Rating (CDR)=0.5 or 1
  • Diagnostic and Statistical Manual-IV(DSM-IV) criteria for dementia
  • National Institute of Aging and the Alzheimer's Association (NIA-AA) Probable AD dementia
  • Study partner or caregiver to accompany patient to all scheduled visits
  • Written informed consent
  • Age : 55 - 90
  • Clinical Dementia Rating (CDR)=0.5
  • Concern regarding a change in cognition (obtained from the subject, from an informant who knows the subject, or from a skilled clinician observing the subject)
  • Lower performance in episodic memory domains that is greater than would be expected for the subject's age and educational background
  • Preservation of independence in functional abilities
  • Study partner or caregiver to accompany subject to all scheduled visits
  • Written informed consent
  • Age : 55 - 90
  • Clinical Dementia Rating (CDR)=0
  • +5 more criteria

You may not qualify if:

  • Past history or presence of major psychiatric illness (e.g. schizophrenia, bipolar disorder, alcohol/substance abuse or dependence, delirium)
  • Significant neurologic or medical condition that can influence the mental state
  • Contraindications for MRI scan (e.g. pacemaker, claustrophobia)
  • Illiteracy
  • Significant visual or hearing difficulty
  • Taking investigational drug
  • In pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, DNA, RNA, hair, and stool

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDisease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dong Young Lee, MD, PhD

    Department of Psychiatry, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 13, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

May 3, 2024

Record last verified: 2024-05

Locations

KR(1)