Back to resultsModeling the Relationships Between Functional Connectivity and Amyloid Deposition in Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
F-18-AV45
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring 18F-FDG PET scan, amyloid PET, Amyloid beta, Alzheimer's disease, metabolic connectivity, functional connectivity
Eligibility Criteria
Inclusion Criteria:
All the participants must meet the following criteria:
- Age between 55-80 years.
- Patients population: Diagnosed as prodromal AD or mild AD dementia based on IWG-2 criteria.
- Normal control population: Cognitive unimpaired individual is defined as normal control in this study. Cognitive un-impaired normal control is defined as cognitive performance in the non-impaired range for that individual, defined as not mild cognitive impairment or demented. The normal control should have their clinical dementia rating score 0 AND Cognitive Ability Screening Instrument (CASI) scores rated >50 percentile.
- Able to provide written informed consent with reliable caregiver in AD population. The participant should have reading ability OR 6/more years of formal education OR with working experiences.
Exclusion Criteria:
All participants must not meet the following criteria:
- Already receive outpatient clinic follow-ups with diseases that may affect the cognitive evaluation or presentation that include but not limited to Parkinsonism, Parkinson's disease dementia, epilepsy, schizophrenia, major depression, major psychiatric disorders, alcohol or drug abuse, major head trauma with consciousness loss.
- Severe progressive or unstable systemic disease that may interfere with the follow-up and test results. These included but not limited to cancer in the past 5 years, end stage renal or liver dysfunction, clinically significant myocardial infarction (New York Heart Association Functional Classification III-IV), Active disease that received admission in the past one year and unstable angina. Other diseases that were not listed but may interfere with the follow-up or test will be judged by the principle investigator.
- Any treatment that suggests any of the aforementioned disease will be excluded.
- Depression with ongoing diagnosis and treatment, suicide idea or suicide behavior in the past 6 months.
- Contraindications or previously failure for receiving brain magnetic resonance imaging or PET scan.
- Pregnant, lactating or breastfeeding.
- Patients with severe liver disease (such as ALT > 3x upper limit of normal).
Sites / Locations
- Chang Gung Memorial Hospital,LinkouRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
F-18-AV45
Arm Description
F-18-AV45 imaging
Outcomes
Primary Outcome Measures
Amyloid Distribution Among Normal, Prodromal AD and AD Dementia Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-AV45 amyloid PET Scan.
Secondary Outcome Measures
Full Information
NCT ID
NCT04174287
First Posted
November 20, 2019
Last Updated
November 20, 2019
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04174287
Brief Title
Modeling the Relationships Between Functional Connectivity and Amyloid Deposition in Alzheimer's Disease
Official Title
Modeling the Relationships Between Functional Connectivity and Amyloid Deposition in Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
March 27, 2023 (Anticipated)
Study Completion Date
September 27, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Glucose is the main energy source of brain. Different neural degenerative diseases such as Parkinson's disease or Alzheimer's disease have shown distinct brain glucose metabolic patterns. FDG-PET is a established non-invasive method to measures cerebral glucose metabolism and can be used to differentiate different types of neurodegenerative diseases that anatomical imaging such as CT or MRI may not be able to differentiate. Among patients whose Alzheimer's diseases have not been confirmed, the defects in brain glucose metabolism can predict future amyloid plaque deposition. On the other hand, early amyloid plaque deposition may predict the future occurrence of Alzheimer's disease as early as 15 years before the onset. This research project is focusing on the sequential change of the two biomarkers of brain glucose metabolism and amyloid plaque deposition and their correlation with clinical symptoms in patients with Alzheimer's disease. The subjects in this project will be including normal controls without cognitive impairment, patients with prodromal AD or AD. The relationship between functional connectivity of FDG-PET and amyloid deposition in different group of patients will be investigated. Further correlation with tau PET will be also discussed.
In the imaging process part of this project, the standard tool, SPM (Spatial Parametric Mapping) will be applied. As machine learning/deep learning methodology is gaining popularity in medical imaging research community, collaboration with artificial intelligence core laboratory at Linkou will be pursued to investigate hidden correlation between functional connectivity, amyloid plaque, progress of clinical symptoms with time that previous statistical methods may not be able to find.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
18F-FDG PET scan, amyloid PET, Amyloid beta, Alzheimer's disease, metabolic connectivity, functional connectivity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
F-18-AV45
Arm Type
Experimental
Arm Description
F-18-AV45 imaging
Intervention Type
Drug
Intervention Name(s)
F-18-AV45
Intervention Description
The study will enroll 200 patients with prodromal AD and mild AD dementia and 100 normal controls, men and women aged 55-80 years across core clinical criteria of prodromal AD and mild AD dementia based on IWG-2 criteria.
Primary Outcome Measure Information:
Title
Amyloid Distribution Among Normal, Prodromal AD and AD Dementia Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-AV45 amyloid PET Scan.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All the participants must meet the following criteria:
Age between 55-80 years.
Patients population: Diagnosed as prodromal AD or mild AD dementia based on IWG-2 criteria.
Normal control population: Cognitive unimpaired individual is defined as normal control in this study. Cognitive un-impaired normal control is defined as cognitive performance in the non-impaired range for that individual, defined as not mild cognitive impairment or demented. The normal control should have their clinical dementia rating score 0 AND Cognitive Ability Screening Instrument (CASI) scores rated >50 percentile.
Able to provide written informed consent with reliable caregiver in AD population. The participant should have reading ability OR 6/more years of formal education OR with working experiences.
Exclusion Criteria:
All participants must not meet the following criteria:
Already receive outpatient clinic follow-ups with diseases that may affect the cognitive evaluation or presentation that include but not limited to Parkinsonism, Parkinson's disease dementia, epilepsy, schizophrenia, major depression, major psychiatric disorders, alcohol or drug abuse, major head trauma with consciousness loss.
Severe progressive or unstable systemic disease that may interfere with the follow-up and test results. These included but not limited to cancer in the past 5 years, end stage renal or liver dysfunction, clinically significant myocardial infarction (New York Heart Association Functional Classification III-IV), Active disease that received admission in the past one year and unstable angina. Other diseases that were not listed but may interfere with the follow-up or test will be judged by the principle investigator.
Any treatment that suggests any of the aforementioned disease will be excluded.
Depression with ongoing diagnosis and treatment, suicide idea or suicide behavior in the past 6 months.
Contraindications or previously failure for receiving brain magnetic resonance imaging or PET scan.
Pregnant, lactating or breastfeeding.
Patients with severe liver disease (such as ALT > 3x upper limit of normal).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TSUNG-YING HO
Phone
03753-66396
Email
albertyho@gmail.com
Facility Information:
Facility Name
Chang Gung Memorial Hospital,Linkou
City
Taoyuan City
State/Province
Guishan Dist
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TSUNG-YING HO
Phone
09753-66396
Email
albertyho@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Modeling the Relationships Between Functional Connectivity and Amyloid Deposition in Alzheimer's Disease
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