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IGF Binding Protein-2 Associated With Cognitive Decline
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 |
|---|
| Alzheimer Disease |
| Study Type : | Observational |
| Estimated 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 : | December 13, 2018 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
- Alzheimer's Disease Assessment Scale-cognitive subscale ADAS-COG [ Time Frame: 24-Months ]Cognitive assessment for dementia
- plasma IGF binding protein -2 [ Time Frame: 24 Months ]Blood test
| Ages Eligible for Study: | 65 Years to 90 Years (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
| Contact: Timothy Kwok, MD | +852 35053145 | tkwok@cuhk.edu.hk | |
| Contact: Hazel Mok, BSc | +852 35053990 | hazelmok@cuhk.edu.hk |
| Hong Kong | |
| The Chinese University of Hong Kon | Recruiting |
| Hong Kong, Hong Kong | |
| Contact: Timothy Kwok, MD +852 35053145 tkwok@cuhk.edu.hk | |
| Contact: Hazel Mok +852 35053990 hazelmok@cuhk.edu.hk | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 8, 2019 | ||||||||
| First Posted Date | May 13, 2019 | ||||||||
| Last Update Posted Date | July 15, 2020 | ||||||||
| Actual Study Start Date | December 13, 2018 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | IGF Binding Protein-2 Associated With Cognitive Decline | ||||||||
| Official Title | Is IGF Binding Protein -2 Associated With Cognitive Decline in Older People With Alzeimer Disease? | ||||||||
| 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Subjects are recruited from the geriatric outpatient clinics or memory clinic. | ||||||||
| Condition | Alzheimer Disease | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2021 | ||||||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 65 Years to 90 Years (Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Hong Kong | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03946930 | ||||||||
| Other Study ID Numbers | 2018.274 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Timothy Kwok, Chinese University of Hong Kong | ||||||||
| Study Sponsor | Chinese University of Hong Kong | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Chinese University of Hong Kong | ||||||||
| Verification Date | July 2020 | ||||||||
