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Alzheimer's DiseasePhase 2NCT02831283

Imaging Inflammation in Alzheimer's Disease

A Phase 2 study testing 11C-PBR28, 18F-Florbetaben and Lumbar puncture (optional) in people with Alzheimer's Disease, run by Patrick Lao at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
11C-PBR28, 18F-Florbetaben and Lumbar puncture (optional)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Jun 2016to Dec 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University irving Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
11C-PBR28, 18F-Florbetaben, Lumbar puncture (optional)
Keywords
inflammation, aging, mild cognitive impairment
Medical subject headings
Alzheimer Disease, Inflammation, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 11C-PBR28Drug

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

    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.

  • 18F-FlorbetabenDrug

    Also called Neuraceq

    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.

  • Lumbar puncture (optional)Procedure or surgery

    Also called LP

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

Study groups in NCT02831283
Study groupRoleWhat they receive
Amyloid-positive with cognitive impairment (AD)ExperimentalAmyloid-positive patients who already have cognitive impairment at the time of enrollment.
Receives: Drug: 11C-PBR28; Drug: 18F-Florbetaben; Procedure: Lumbar puncture (optional)
Amyloid-positive without impairment (preclinical AD)Active comparatorCognitively normal subjects who are amyloid-positive
Receives: Drug: 11C-PBR28; Drug: 18F-Florbetaben; Procedure: Lumbar puncture (optional)
Amyloid-negative with cognitive impairmentActive comparatorParticipants with cognitive impairment due to suspected non-AD pathophysiology
Receives: Drug: 11C-PBR28; Drug: 18F-Florbetaben; Procedure: Lumbar puncture (optional)
Amyloid-negative without impairment (normal aging)Active comparatorCognitively normal subjects who are amyloid-negative on PET, and lack signs of neurodegeneration from other biomarkers
Receives: Drug: 11C-PBR28; Drug: 18F-Florbetaben; Procedure: Lumbar puncture (optional)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 11C-PBR28 Binding

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

    Measured: Up to 1 year from screening

Secondary outcomes (2)

  1. 18F-Florbetaben Binding

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

    Measured: Up to 1 year from screening

  2. Cerebral Spinal Fluid (CSF) Biomarkers

    Protein analysis of cerebral spinal fluid.

    Measured: Up to 1 year from screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2022
  4. Study completionDec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02831283
Sponsor's protocol ID
AAAO1151
Other IDs
1K23AG052633-01
Status last verified
Feb 2025
First submitted
10 Jul 2016
Last updated
5 Mar 2025
Data monitoring committee
No

Publications

  • Klein J, Yan X, Johnson A, Tomljanovic Z, Zou J, Polly K, Honig LS, Brickman AM, Stern Y, Devanand DP, Lee S, Kreisl WC. Olfactory Impairment Is Related to Tau Pathology and Neuroinflammation in Alzheimer's Disease. J Alzheimers Dis. 2021;80(3):1051-1065. doi: 10.3233/JAD-201149.

    PubMed 33646153

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 11C-PBR28, 18F-Florbetaben and Lumbar puncture (optional) in people with Alzheimer's Disease, run by Patrick Lao at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

11C-PBR28 Binding (time frame: Up to 1 year from screening). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02831283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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