Imaging Inflammation in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies

NCT02702102 | Completed Phase 2 Results

• 2 other identifiers: AAAQ07562P50AG008702-26
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses a special type of scan called a positron emission tomography (PET) scan to take pictures of the brain. During the PET scan, a special dye called 11C-PBR28 is injected into the body. 11C-PBR28 sticks to parts of the brain where there is inflammation. The purpose of this study is to see if 11C-PBR28 can detect inflammation in patients with Parkinson's disease dementia or dementia with Lewy bodies. 11C-PBR28 is considered a drug by the Food and Drug Administration. 11C-PBR28 is not a treatment for any disease. Rather, 11C-PBR28 can be used to measure inflammation in the brain.

Conditions

Diffuse Lewy Body Disease; Dementia With Lewy Bodies; Parkinson's Disease Dementia

Outcome Measures

Primary Outcomes (1)

• Absolute 11C-PBR28 Binding (Total Distribution Volume Corrected for Free Fraction in Plasma)

  Using Arterial blood sampling and 11C-PBR28 PET scan uptake, a Vt was found (as opposed to an SUVR) for target regions. Volume of distribution (VT) of a radioligand is defined as the ratio of the radioligand concentration in tissue target region (CT, kBq·cm-3) to that in plasma (CP, kBq·mL-1) at equilibrium.

  1 year

Secondary Outcomes (1)

• Relative 11C-PBR28 Binding

  1 year

Study Arms (1)

11C-PBR28 PET scans

EXPERIMENTAL

Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28.

Drug: 11C-PBR28

Interventions

11C-PBR28 DRUG

Up to 20 millicuries

Also known as: Non-proprietary

11C-PBR28 PET scans

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 and older.
• Meet criteria for either a) dementia with Lewy bodies, or b) Parkinson's disease dementia.
• 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, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
• Age 60 and older.
• Normal cognitive and motor function based on neurological examination.
• 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, the subject 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 other brain disorders.
• Certain significant medical conditions. Examples are uncontrolled epilepsy or 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 subjects above the allowable limits.
• Low affinity binding on TSPO genetic screen
• Currently taking anticoagulant drugs (e.g., warfarin).
• Women of childbearing potential.

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Lewy Body Disease

Interventions

(methyl-(11)C)N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: William Kreisl, MD
• Organization: Columbia University

wck2107@cumc.columbia.edu

212-305-9194

Study Officials

• William Kreisl, MD

  Columbia University

  STUDY DIRECTOR

• Patrick Lao, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurological Sciences

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 8, 2016
• Study Start: December 1, 2015
• Primary Completion: September 4, 2019
• Study Completion: September 4, 2019
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)