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IGF Binding Protein-2 Associated With Cognitive Decline

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT03946930
Collaborator
(none)
500
Enrollment
1
Location
84.6
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is lack of information on the risk factors of accelerated cognitive decline in older people with Alzheimer disease (AD). The extent of neurodegeneration and white matter disease has been reported to be important factors. In addition there may be biomarkers e.g. inflammatory cytokines that can contribute to cognitive decline. The impact of care arrangement and physical activity may also be important. Insulin signaling is impaired in Alzheimer disease (AD). Insulin and Insulin growth factor (IGF) pathways are closely related. IGF in the brain is in turn modulated especially by IGF binding protein -2. Higher plasma IGF binding protein -2 was associated with brain atrophy in older people.

We therefore propose to perform a cohort study to test the hypothesis that higher plasma IGF binding protein-2 is independently associated with greater cognitive decline in older people with AD. This will be based on an on-going AD registry which was designed to identify genetic biomarkers for AD. Detailed neurocognitive tests and lifestyle information are available. In addition, volumetric MRI brain scans were performed in all AD subjects. The hypothesis is that MRI brain volumes, serum biomarkers, physical activity, physical functioning are independently associated with cognitive decline in older people with AD. The objective is to identify risk factors of accelerated cognitive decline so that preventive measures can be designed to delay dependency in AD.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Is IGF Binding Protein -2 Associated With Cognitive Decline in Older People With Alzeimer Disease?
    Actual Study Start Date :
    Dec 13, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Alzheimer's Disease Assessment Scale-cognitive subscale ADAS-COG [24-Months]

      Cognitive assessment for dementia

    2. plasma IGF binding protein -2 [24 Months]

      Blood test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Sufficient Cantonese competency for cognitive test

    • Clinical diagnosis of AD

    • FAST test staging 3-5

    Exclusion Criteria:

    • Subjects who refuse blood taking procedure

    • No reliable family caregiver informant (person contact at least once a month)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Chinese University of Hong Kon Hong Kong Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Timothy Kwok, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT03946930
    Other Study ID Numbers:
    • 2018.274
    First Posted:
    May 13, 2019
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Jul 28, 2021