- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02831283
Imaging Inflammation in Alzheimer's Disease
September 16, 2022 updated by: James M Noble, MD, MS, CPH, FAAN
Imaging Inflammation in Elders With Different Clinical and Biomarker Profiles of Alzheimer's Disease
This study is being done to learn about inflammation and amyloid in Alzheimer's disease.
A type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in the brain.
These are thought to be involved in Alzheimer's disease.
The investigators will also perform brain MRI and do tests to measure the participants' memory and thinking.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
This study is being done to determine the relationship between inflammation, cognitive impairment, and amyloid burden in elderly subjects with different clinical and biomarker profiles of Alzheimer's disease (AD).
Participants will undergo amyloid PET imaging with 18F-Florbetaben with target number of completers being 15 amyloid-positive elders with impairment, 15 amyloid-positive elders with normal cognition, 15 amyloid-negative elders with impairment, and 15 amyloid-negative elders with normal cognition.
Subjects will undergo screen that includes neuropsychological testing, brain MRI, and PET imaging with 18F-florbetaben to define the above 4 groups.
Subjects will have 11C-PBR28 PET imaging to measure the 18 kDa translocator protein (a marker of inflammation).
Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of amyloid,tau, phospho-tau, and inflammatory markers.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 60 and older.
- Meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or mild Alzheimer's disease, or b) have no cognitive impairment based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
- Subjects unable to provide informed consent must have a surrogate decision maker
- Written and oral fluency in English or Spanish.
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
- In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
Exclusion Criteria:
- Past or present history of certain brain disorders other than MCI or AD.
- Certain significant medical conditions, which make study procedures of the current study unsafe.
- Contraindication to MRI scanning.
- Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.).
- Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
- Low affinity binding on TSPO genetic screen.
- Participation in the last year in a clinical trial for a disease modifying drug for AD.
- Inability to have a catheter in subject's vein for the injection of radioligand.
- Inability to have blood drawn from subject's veins.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive impairment
Alzheimer's disease, Preclinical Alzheimer's disease or Impairment due to suspected non-Alzheimer's disease pathophysiology
|
11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation.
11C-PBR28 has previously been administered in humans.
11C-PBR28 will be administered at activity of up to 20 mCi per injection.
Other Names:
18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease.
18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.
Other Names:
Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.
Other Names:
|
Active Comparator: No cognitive impairment
Normal aging
|
11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation.
11C-PBR28 has previously been administered in humans.
11C-PBR28 will be administered at activity of up to 20 mCi per injection.
Other Names:
18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease.
18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.
Other Names:
Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
11C-PBR28 binding (standardized uptake value ratio)
Time Frame: Up to 1 year from screening
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In vivo quantification radioligand binding to TSPO expression on microglia in the brain.
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Up to 1 year from screening
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
18F-Florbetaben binding (standardized uptake value ratio)
Time Frame: Up to 1 year from screening
|
In vivo quantification of radioligand binding to Amyloid-Beta protein in the brain.
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Up to 1 year from screening
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Cerebral spinal fluid (CSF) biomarkers
Time Frame: Up to 1 year from screening
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Protein analysis of cerebral spinal fluid.
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Up to 1 year from screening
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James M. Noble, MD, MS, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
July 10, 2016
First Submitted That Met QC Criteria
July 10, 2016
First Posted (Estimate)
July 13, 2016
Study Record Updates
Last Update Posted (Actual)
September 19, 2022
Last Update Submitted That Met QC Criteria
September 16, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAO1151
- 1K23AG052633-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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