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History of Changes for Study: NCT02831283
Imaging Inflammation in Alzheimer's Disease
Latest version (submitted September 16, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 10, 2016 None (earliest Version on record)
2 December 7, 2016 Study Status, Sponsor/Collaborators and Study Identification
3 December 11, 2017 Study Status
4 January 9, 2018 Recruitment Status, Study Status and Contacts/Locations
5 January 30, 2019 Study Status
6 July 17, 2020 Outcome Measures, Study Status and Arms and Interventions
7 August 4, 2021 Study Status
8 September 16, 2022 Sponsor/Collaborators, Study Status and Contacts/Locations
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Study NCT02831283
Submitted Date:  July 10, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: AAAO1151
Brief Title: Imaging Inflammation in Alzheimer's Disease
Official Title: Imaging Inflammation in Elders With Different Clinical and Biomarker Profiles of Alzheimer's Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2016
Overall Status: Recruiting
Study Start: June 2016
Primary Completion: June 2021 [Anticipated]
Study Completion: June 2021 [Anticipated]
First Submitted: July 10, 2016
First Submitted that
Met QC Criteria:
July 10, 2016
First Posted: July 13, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 10, 2016
Last Update Posted: July 13, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: William Charles Kreisl
Responsible Party: Sponsor-Investigator
Investigator: William Charles Kreisl
Official Title: Boris and Rose Katz Assistant Professor of Neurology (in the Taub Institute)
Affiliation: Columbia University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
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.
Open or close this module Conditions
Conditions: Alzheimer's Disease
Keywords: inflammation
aging
mild cognitive impairment
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cognitive impairment
Alzheimer's disease, Preclinical Alzheimer's disease or Impairment due to suspected non-Alzheimer's disease pathophysiology
Drug: 11C-PBR28
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.
Drug: 18F-Florbetaben
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:
  • Neuraceq
Procedure: Lumbar puncture (optional)
Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.
Active Comparator: No cognitive impairment
Normal aging
Drug: 11C-PBR28
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.
Drug: 18F-Florbetaben
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:
  • Neuraceq
Procedure: Lumbar puncture (optional)
Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 11C-PBR28 binding (standardized uptake value ratio)
[ Time Frame: Up to 1 year from screening ]

Secondary Outcome Measures:
1. 18F-Florbetaben binding (standardized uptake value ratio)
[ Time Frame: Up to 1 year from screening ]

2. Cerebral spinal fluid (CSF) biomarkers
[ Time Frame: Up to 1 year from screening ]

Open or close this module Eligibility
Minimum Age: 60 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  1. Age 60 and older.
  2. 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.
  3. Subjects unable to provide informed consent must have a surrogate decision maker
  4. Written and oral fluency in English or Spanish.
  5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
  6. 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:

  1. Past or present history of certain brain disorders other than MCI or AD.
  2. Certain significant medical conditions, which make study procedures of the current study unsafe.
  3. Contraindication to MRI scanning.
  4. Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.).
  5. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
  6. Low affinity binding on TSPO genetic screen.
  7. Participation in the last year in a clinical trial for a disease modifying drug for AD.
  8. Inability to have a catheter in subject's vein for the injection of radioligand.
  9. Inability to have blood drawn from subject's veins.
Open or close this module Contacts/Locations
Central Contact Person: William C Kreisl, MD
Telephone: 212-342-2380
Email: wck2107@cumc.columbia.edu
Central Contact Backup: Solciris A Dominguez, MD
Telephone: 212-342-2380
Email: sc4032@cumc.columbia.edu
Study Officials: William C Kreisl, MD
Principal Investigator
Columbia University
Locations: United States, New York
Columbia University Medical Center
[Recruiting]
New York, New York, United States, 10032
Contact:Contact: William C Kreisl, MD 212-342-2380 wck2107@cumc.columbia.edu
Contact:Contact: Solciris A Dominguez, MD 212-342-2380 sc4032@cumc.columbia.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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