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

NCT03744312 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AAAR6570
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Inflammation; PET scans

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to one year from baseline

Secondary Outcomes (1)

• 11C-ER176 Standardized Uptake Value Ratio

  Up to one year from baseline

Study Arms (2)

Cognitive impairment

EXPERIMENTAL

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

Drug: 11C-ER176; Drug: Florbetaben

No cognitive impairment

ACTIVE COMPARATOR

Healthy Controls

Drug: 11C-ER176; Drug: Florbetaben

Interventions

11C-ER176 DRUG

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.

Also known as: [11C] ER176

Cognitive impairment; No cognitive impairment

Florbetaben DRUG

Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.

Also known as: NeuraCeq

Cognitive impairment; No cognitive impairment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Inflammation

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Patrick J. Lao, PhD
• Organization: Columbia University

pjl2133@cumc.columbia.edu

212-305-9079

Study Officials

• Patrick Lao, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Sciences

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: September 10, 2018
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: April 17, 2025
• Results First Posted: September 13, 2023

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Up to two weeks after review and approval of request.
• Access Criteria: Investigator qualifications and previous work will be reviewed by PI. Subsequent email correspondence will relay technical criteria needed for access.

Locations

US (1)