Phase 2
N=9
Imaging Inflammation in Alzheimer's Disease With 11C-ER176
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03744312 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: 11C-ER176 Total Distribution Volume — 6.27; 9.32 mL/cm^3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 11C-ER176 (Drug); Florbetaben (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 11C-ER176 Total Distribution Volume |
6.27; 9.32 | — |
| SECONDARY 11C-ER176 Standardized Uptake Value Ratio |
1.19; 1.22 | — |
Summary
This study is being done to learn about inflammation in the brain of those with Alzheimer's disease (AD). The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. Both patients (with either mild cognitive impairment (MCI) or Alzheimer's disease) and healthy controls (participants without memory complaints or impairment) will be included in this study.
Eligibility Criteria
Inclusion Criteria
- Age 50 and older
- Meet criteria for either a) amnestic mild cognitive impairment or Alzheimer's disease, or b) have no cognitive impairment
- If you are unable to provide informed consent, you must have a surrogate decision maker and be able to verbally assent to the study procedures
- Written and oral fluency in English
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
- In the opinion of the investigator, you 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. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
- 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 you above the allowable limits.
- Participation in the last year in a clinical trial for a disease modifying drug for AD.
- Inability to have a catheter in your vein for the injection of radioligand.
- Inability to have blood drawn from your veins.
- Taking anticoagulant medication (e.g., warfarin).
Data sourced from ClinicalTrials.gov (NCT03744312). 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.