Multimodal Biomarkers for Diagnosis and Prognosis in VCI (VCI)
Primary Purpose
Vascular Cognitive Impairment, Alzheimer Disease
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
amyloid PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Vascular Cognitive Impairment focused on measuring Vascular Cognitive Impairment, ApoE genotype, Amyloid PET, Brain MRI
Eligibility Criteria
Inclusion Criteria:
-
I. Vascular cognitive impairment patients:
- Age older than 20 years.
Clinical diagnosis:
- At least one obstacle to executive function, attention, memory, language and visual space function.
- Affected activities of daily living.
- Brain MRI showing cerebrovascular disease.
- Patient agrees to participate in the study and is willing to receive 11C-PiB PET.
II. Alzheimer's disease (AD) patients:
- Age older than 20 years.
Clinical diagnosis:
- Amnesia or non-amnesia (language, visual space, executive ability) performance.
- Affected activities of daily living.
- Patient agrees to participate in the study and is willing to receive 11C-PiB PET.
III. Normal controls:
- Age older than 20 years.
- No neurological or psychiatric history.
- Patient agrees to participate in the study and is willing to receive 11C-PiB PET.
Exclusion Criteria:
-
I. Vascular cognitive impairment patients:
- Have other illnesses, including people with drug / alcohol abuse / addictivity within three months.
- Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
- Pregnant woman or intends to be pregnant in the near future.
- Patient who is breast feeding or intends to.
- Allergic to 11C-PiB, or with severe drug allergy history.
- Patient or the family refuses to participate in the study.
II. Alzheimer's disease (AD) patients:
Have other illnesses, including:
- Cognitive disorders caused by cerebrovascular diseases (the decline in cognitive function is closely related to the time of stroke, multiple large-scale necrosis, and severe white matter lesions).
- The main manifestation of dementia is Lewy body dementia
- Symptoms are behavioral variation of frontotemporal dementia.
- The symptoms are obviously semantic progressive aphasia.
- Symptoms are not fluent in primary progressive aphasia.
- Other comorbidities that affect cognitive function (including other active neurological diseases, or non-neurological diseases but the disease or the treatment used will affect cognitive function)
- Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
- Pregnant woman or intends to be pregnant in the near future.
- Patient who is breast feeding or intends to.
- Allergic to 11C-PiB, or with severe drug allergy history.
- Patient or the family refuses to participate in the study.
III. Normal controls:
- Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
- Pregnant woman or intends to be pregnant in the near future.
- Patient who is breast feeding or intends to.
- Allergic to 11C-PiB, or with severe drug allergy history.
- Patient or the family refuses to participate in the study.
- high risk as assessed by a doctor.
Sites / Locations
- National Taiwan Univeristy HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
amyloid PET、T807 PET
Arm Description
PET/CT
Outcomes
Primary Outcome Measures
PET imaging
PET data will reconstruct with ordered set expectation maximization, corrected for attenuation, and each frame will be evaluated to verify adequate count statistics and absence of head motion.
Secondary Outcome Measures
Full Information
NCT ID
NCT04604600
First Posted
October 21, 2020
Last Updated
October 26, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04604600
Brief Title
Multimodal Biomarkers for Diagnosis and Prognosis in VCI
Acronym
VCI
Official Title
Multimodal Biomarkers for Diagnosis and Prognosis in Vascular Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
We will try to
establish the correlation of plasma Aβ40 and Aβ42 level, ApoE genotype, MRI imaging markers in the diagnosis and prognosis of VCI patients
understand more on the pathophysiology of VCI.
Detailed Description
Background and objectives Owing to the aging problem, cognitive impairment has been a worldwide health issue. Vascular cognitive impairment (VCI) and Alzheimer's disease (AD) are the two most common causes. It has been reported that VCI and AD share many common risk factors. MRI is essential in assessing the extent, location and type of vascular lesions. Amyloid PET has been used in detecting cerebral amyloid burden non-invasively since 2004. There are only small number of studies using amyloid PET in VCI and the results are still controversial. In the current proposal, we will investigate
the correlation of clinical risk factors, ApoE genotype, various MRI markers, and amyloid PET expression
assess the influence of ApoE genotype on different biomarkers, including MRI markers, amyloid retention, and plasma Aβ40 and Aβ42 levels
the potential of amyloid PET as a prognostic factor for VCI patients.
Materials and methods This study will be conducted in National Taiwan University Hospital and Bei-Hu Branch Hospital. Sixty clinical diagnosed VCI, 30 AD patients and 30 normal subjects will be enrolled in this 3-year prospective study. We will collect vascular risk factors, neuropsychological tests, 10 cc venous blood for plasma Aβ40, Aβ42, total tau and phosphorylated level measurement by IMR assay, ApoE genotype, brain MRI, and amyloid PET of each patient and control subject. All the data will be analyzed together.
Expected Results We will try to
establish the correlation of plasma Aβ40 and Aβ42 level, ApoE genotype, MRI imaging markers in the diagnosis and prognosis of VCI patients
understand more on the pathophysiology of VCI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Cognitive Impairment, Alzheimer Disease
Keywords
Vascular Cognitive Impairment, ApoE genotype, Amyloid PET, Brain MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
amyloid PET、T807 PET
Arm Type
Experimental
Arm Description
PET/CT
Intervention Type
Drug
Intervention Name(s)
amyloid PET
Intervention Description
Dynamic PET acquisition for 70 minutes will be acquired after injection of 10±5 mCi 11C-PiB.
Primary Outcome Measure Information:
Title
PET imaging
Description
PET data will reconstruct with ordered set expectation maximization, corrected for attenuation, and each frame will be evaluated to verify adequate count statistics and absence of head motion.
Time Frame
in 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-
I. Vascular cognitive impairment patients:
Age older than 20 years.
Clinical diagnosis:
At least one obstacle to executive function, attention, memory, language and visual space function.
Affected activities of daily living.
Brain MRI showing cerebrovascular disease.
Patient agrees to participate in the study and is willing to receive 11C-PiB PET.
II. Alzheimer's disease (AD) patients:
Age older than 20 years.
Clinical diagnosis:
Amnesia or non-amnesia (language, visual space, executive ability) performance.
Affected activities of daily living.
Patient agrees to participate in the study and is willing to receive 11C-PiB PET.
III. Normal controls:
Age older than 20 years.
No neurological or psychiatric history.
Patient agrees to participate in the study and is willing to receive 11C-PiB PET.
Exclusion Criteria:
-
I. Vascular cognitive impairment patients:
Have other illnesses, including people with drug / alcohol abuse / addictivity within three months.
Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
Pregnant woman or intends to be pregnant in the near future.
Patient who is breast feeding or intends to.
Allergic to 11C-PiB, or with severe drug allergy history.
Patient or the family refuses to participate in the study.
II. Alzheimer's disease (AD) patients:
Have other illnesses, including:
Cognitive disorders caused by cerebrovascular diseases (the decline in cognitive function is closely related to the time of stroke, multiple large-scale necrosis, and severe white matter lesions).
The main manifestation of dementia is Lewy body dementia
Symptoms are behavioral variation of frontotemporal dementia.
The symptoms are obviously semantic progressive aphasia.
Symptoms are not fluent in primary progressive aphasia.
Other comorbidities that affect cognitive function (including other active neurological diseases, or non-neurological diseases but the disease or the treatment used will affect cognitive function)
Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
Pregnant woman or intends to be pregnant in the near future.
Patient who is breast feeding or intends to.
Allergic to 11C-PiB, or with severe drug allergy history.
Patient or the family refuses to participate in the study.
III. Normal controls:
Patient cannot accept brain magnetic resonance imaging or 11C-PiB PET, such as agitation and inability to cooperate, allergy to contrast agents, hemodynamic instability (blood pressure, pulse, or blood oxygen is not in the normal range), and a heart rhythm regulator has been implanted , Have ever undergone intracranial aneurysm clamp surgery, claustrophobia and hemodynamic instability.
Pregnant woman or intends to be pregnant in the near future.
Patient who is breast feeding or intends to.
Allergic to 11C-PiB, or with severe drug allergy history.
Patient or the family refuses to participate in the study.
high risk as assessed by a doctor.
Facility Information:
Facility Name
National Taiwan Univeristy Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yen Ruoh Fang, MD, PhD
Phone
886-2-23123456
Ext
65581
Email
rfyen@ntu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Multimodal Biomarkers for Diagnosis and Prognosis in VCI
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