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Imaging Inflammation in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT02831283
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2016
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
William Charles Kreisl, Columbia University

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: 11C-PBR28 Drug: 18F-Florbetaben Procedure: Lumbar puncture (optional) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging Inflammation in Elders With Different Clinical and Biomarker Profiles of Alzheimer's Disease
Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: Neuraceq

Procedure: Lumbar puncture (optional)
Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831283


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
William Charles Kreisl
National Institute on Aging (NIA)
Investigators
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Principal Investigator: William C Kreisl, MD Columbia University

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Responsible Party: William Charles Kreisl, Boris and Rose Katz Assistant Professor of Neurology (in the Taub Institute), Columbia University
ClinicalTrials.gov Identifier: NCT02831283     History of Changes
Other Study ID Numbers: AAAO1151
1K23AG052633-01 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Keywords provided by William Charles Kreisl, Columbia University:
inflammation
aging
mild cognitive impairment

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Inflammation
Pathologic Processes
Dementia
Tauopathies