Columbia University irving Medical Center
New York, 10032, United States
NCT Number: NCT02831283
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.
Looking for future studies?
Notify Me60 year and older
All sexes
Interventional
Phase 2
New York, 10032, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 (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
Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.
Other names: LP
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).
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).
Time frame: Up to 1 year from screening
Protein analysis of cerebral spinal fluid.
Patrick Lao
Other
Imaging Inflammation in Elders With Different Clinical and Biomarker Profiles of Alzheimer's Disease
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.
Published trials that share one or more normalized conditions with this study.
NCT04396873
ALS, Alzheimer Disease
Bethesda, Maryland, United States
View Trial DetailsNCT05463731
Alzheimer Disease, Alzheimer's Disease
Chandler, Arizona, United States
View Trial DetailsNCT04073628
Alzheimer Disease, Alzheimer's Disease
Albany, New York, United States
View Trial DetailsNCT00647478
Alzheimer Disease, Alzheimer's Disease
Paris, France
View Trial Details