A Phase 2 interventional study of 11C-PBR28 and 18F-Florbetaben in Alzheimer's Disease, sponsored by Patrick Lao. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Patrick Lao · Phase 2, Interventional, and Diagnostic
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.
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Patrick Lao is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Amyloid-positive patients who already have cognitive impairment at the time of enrollment.
Drug: 11C-PBR28 · Drug: 18F-Florbetaben · Procedure: Lumbar puncture (optional)
Cognitively normal subjects who are amyloid-positive
Drug: 11C-PBR28 · Drug: 18F-Florbetaben · Procedure: Lumbar puncture (optional)
Participants with cognitive impairment due to suspected non-AD pathophysiology
Drug: 11C-PBR28 · Drug: 18F-Florbetaben · Procedure: Lumbar puncture (optional)
Cognitively normal subjects who are amyloid-negative on PET, and lack signs of neurodegeneration from other biomarkers
Drug: 11C-PBR28 · Drug: 18F-Florbetaben · Procedure: Lumbar puncture (optional)
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.
Also known as: 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.
Also known as: Neuraceq
Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.
Also known as: LP
11C-PBR28 Binding
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
18F-Florbetaben Binding
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
Cerebral Spinal Fluid (CSF) Biomarkers
Protein analysis of cerebral spinal fluid.
Time frame: Up to 1 year from screening
| Milestone | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive Without Impairment (Preclinical AD) | Amyloid-negative With Cognitive Impairment | Amyloid-negative Without Impairment (Normal Aging) |
|---|---|---|---|---|
| Started | 24 | 8 | 11 | 17 |
| Completed | 24 | 8 | 11 | 17 |
| Not completed | 0 | 0 | 0 | 0 |
In vivo quantification radioligand binding to TSPO expression on microglia in the brain, reported as standardized uptake value ratio (SUVR).
| SUVR | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive Without Impairment (Preclinical AD) | Amyloid-negative With Cognitive Impairment | Amyloid-negative Without Impairment (Normal Aging) |
|---|---|---|---|---|
| 11C-PBR28 Binding | 1.25 ± 0.18 | 1.15 ± 0.16 | 1.16 ± 0.16 | 1.02 ± 0.13 |
In vivo quantification of radioligand binding to Amyloid-Beta protein in the brain, reported as standardized uptake value ratio (SUVR).
| SUVR | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive Without Impairment (Preclinical AD) | Amyloid-negative With Cognitive Impairment | Amyloid-negative Without Impairment (Normal Aging) |
|---|---|---|---|---|
| 18F-Florbetaben Binding | 1.64 ± 0.18 | 1.51 ± 0.14 | 1.17 ± 0.14 | 1.12 ± 0.06 |
Protein analysis of cerebral spinal fluid.
| ng/mL | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive Without Impairment (Preclinical AD) | Amyloid-negative With Cognitive Impairment | Amyloid-negative Without Impairment (Normal Aging) |
|---|---|---|---|---|
| Cerebral Spinal Fluid (CSF) Biomarkers | 3.14 ± 1.69 | 4.21 ± 1.74 | 3.26 ± 2.99 | 2.05 ± 0.57 |
Collected over Up to 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amyloid-positive With Cognitive Impairment (AD) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Amyloid-positive Without Impairment (Preclinical AD) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Amyloid-negative With Cognitive Impairment | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Amyloid-negative Without Impairment (Normal Aging) | 0/17 (0%) | 0/17 (0%) | 2/17 (11.8%) |
| Event | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive Without Impairment (Preclinical AD) | Amyloid-negative With Cognitive Impairment | Amyloid-negative Without Impairment (Normal Aging) |
|---|---|---|---|---|
| Soreness at IV injection siteGeneral disorders | 0/24 | 0/8 | 0/11 | 1/17 |
| HeadacheGeneral disorders | 0/24 | 0/8 | 0/11 | 1/17 |
| Age, Continuous(years) | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive Without Impairment (Preclinical AD) | Amyloid-negative With Cognitive Impairment | Amyloid-negative Without Impairment (Normal Aging) | Total |
|---|---|---|---|---|---|
| Mean | 65.2 ± 8.7 | 73.8 ± 3.1 | 75.8 ± 9.8 | 67.6 ± 3.8 | 68.8 ± 8.3 |
| Sex: Female, Male(Participants) | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive Without Impairment (Preclinical AD) | Amyloid-negative With Cognitive Impairment | Amyloid-negative Without Impairment (Normal Aging) | Total |
|---|---|---|---|---|---|
| Female | 4 | 4 | 7 | 5 | 20 |
| Male | 20 | 4 | 4 | 12 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive Without Impairment (Preclinical AD) | Amyloid-negative With Cognitive Impairment | Amyloid-negative Without Impairment (Normal Aging) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 1 | 2 | 6 |
| Not Hispanic or Latino | 21 | 8 | 10 | 15 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Amyloid-positive With Cognitive Impairment (AD) | Amyloid-positive Without Impairment (Preclinical AD) | Amyloid-negative With Cognitive Impairment | Amyloid-negative Without Impairment (Normal Aging) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 1 | 6 | 9 |
| White | 24 | 6 | 10 | 11 | 51 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: (methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine