Phase 2
N=60
Imaging Inflammation in Alzheimer's Disease
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02831283 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: 11C-PBR28 Binding — 1.25; 1.15; 1.16; 1.02 SUVR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 11C-PBR28 (Drug); 18F-Florbetaben (Drug); Lumbar puncture (optional) (Procedure)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Patrick Lao
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 11C-PBR28 Binding |
1.25; 1.15; 1.16; 1.02 | — |
| SECONDARY 18F-Florbetaben Binding |
1.64; 1.51; 1.17; 1.12 | — |
| SECONDARY Cerebral Spinal Fluid (CSF) Biomarkers |
3.14; 4.21; 3.26; 2.05 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02831283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.