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Imaging Inflammation in Alzheimer's Disease With 11C-ER176

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
11C-ER176
Florbetaben
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Inflammation, PET scans

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 50 and older
  2. Meet criteria for either a) amnestic mild cognitive impairment or Alzheimer's disease, or b) have no cognitive impairment
  3. 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
  4. Written and oral fluency in English
  5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
  6. 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:

  1. Past or present history of certain brain disorders other than MCI or AD.
  2. Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
  3. Contraindication to MRI scanning
  4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
  5. Exposure to research related radiation in the past year that, when combined with this study, would place you above the allowable limits.
  6. Participation in the last year in a clinical trial for a disease modifying drug for AD.
  7. Inability to have a catheter in your vein for the injection of radioligand.
  8. Inability to have blood drawn from your veins.
  9. Taking anticoagulant medication (e.g., warfarin).

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive impairment

No cognitive impairment

Arm Description

Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)

Healthy Controls

Outcomes

Primary Outcome Measures

11C-ER176 Total Distribution Volume
Total distribution volume reflects the amount of TSPO (the inflammatory protein that 11C-ER176 sticks to) in the brain. This measure requires arterial blood sampling.

Secondary Outcome Measures

11C-ER176 Standardized Uptake Value Ratio
The standardize uptake value ratio is the concentration of radioactivity measured from the 11C-ER176 positron emission tomography (PET) scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region). This is a simplified quantification technique compared to the Total Distribution Volume, but is linearly related to it. Higher values indicate more neuroinflammation.

Full Information

First Posted
November 14, 2018
Last Updated
August 30, 2023
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03744312
Brief Title
Imaging Inflammation in Alzheimer's Disease With 11C-ER176
Official Title
Imaging Inflammation in Alzheimer's Disease With 11C-ER176
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Inflammation likely plays a role in the damage to the brain caused by Alzheimer's disease. Accurately measuring inflammation in the brain could provide new information about the mechanisms that cause Alzheimer's disease, and could help identify new treatments that reduce inflammation. Positron emission tomography (PET) imaging is a type of brain scanning method that allows investigators to measure small molecules in the brain. ER176-PET was recently developed as an improved method for measuring brain inflammation. However, ER176-PET has not yet been used in patients with Alzheimer's disease. The investigators propose to use ER176-PET imaging in subjects with mild cognitive impairment (a very early stage of Alzheimer's disease) or mild Alzheimer's disease to compare the amount of inflammation with that seen in older control subjects. The investigators will first use a "gold standard" method of measuring ER176 in brain that requires sampling arterial blood during the scan. The investigators will compare these results to those obtained using novel methods that don't require blood sampling. The investigators hope to show that ER176 is a useful tool for measuring inflammation in Alzheimer's disease, and that the investigators can develop a way to obtain ER176 PET scans that don't require arterial blood sampling. This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special dye is injected into the body. Two types of dye will be used in this study: Florbetaben and 11C-ER176. Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease. Florbetaben has been approved by the Food and Drug Administration to help diagnose Alzheimer's disease. 11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Inflammation, PET scans

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive impairment
Arm Type
Experimental
Arm Description
Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)
Arm Title
No cognitive impairment
Arm Type
Active Comparator
Arm Description
Healthy Controls
Intervention Type
Drug
Intervention Name(s)
11C-ER176
Other Intervention Name(s)
[11C] ER176
Intervention Description
11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
Intervention Type
Drug
Intervention Name(s)
Florbetaben
Other Intervention Name(s)
NeuraCeq
Intervention Description
Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
Primary Outcome Measure Information:
Title
11C-ER176 Total Distribution Volume
Description
Total distribution volume reflects the amount of TSPO (the inflammatory protein that 11C-ER176 sticks to) in the brain. This measure requires arterial blood sampling.
Time Frame
Up to one year from baseline
Secondary Outcome Measure Information:
Title
11C-ER176 Standardized Uptake Value Ratio
Description
The standardize uptake value ratio is the concentration of radioactivity measured from the 11C-ER176 positron emission tomography (PET) scan in the cortex compared to the uptake in the cerebellum (pseudo-reference region). This is a simplified quantification technique compared to the Total Distribution Volume, but is linearly related to it. Higher values indicate more neuroinflammation.
Time Frame
Up to one year from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Lao, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be available upon reasonable request from a qualified investigator.
IPD Sharing Time Frame
Up to two weeks after review and approval of request.
IPD Sharing Access Criteria
Investigator qualifications and previous work will be reviewed by PI. Subsequent email correspondence will relay technical criteria needed for access.

Learn more about this trial

Imaging Inflammation in Alzheimer's Disease With 11C-ER176

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