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OpenTrials
Completed

NCT Number: NCT02831283

Imaging Inflammation in 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

11C-PBR28

Drug

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: 11C-[O-methyl-11C]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine

18f-florbetaben

Drug

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

Lumbar Puncture (optional)

Procedure

Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.

Other names: LP

Primary outcomes

  1. 11C-PBR28 Binding

    Time frame: Up to 1 year from screening

    In vivo quantification radioligand binding to TSPO expression on microglia in the brain, reported as standardized uptake value ratio (SUVR).

Secondary outcomes

  1. 18F-Florbetaben Binding

    Time frame: Up to 1 year from screening

    In vivo quantification of radioligand binding to Amyloid-Beta protein in the brain, reported as standardized uptake value ratio (SUVR).

  2. Cerebral Spinal Fluid (CSF) Biomarkers

    Time frame: Up to 1 year from screening

    Protein analysis of cerebral spinal fluid.

Sponsors and collaborators

Lead sponsor

Patrick Lao

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Imaging Inflammation in Elders With Different Clinical and Biomarker Profiles of Alzheimer's Disease

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 13, 2016
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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