Trial Outcomes & Findings for Imaging Inflammation in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies (NCT NCT02702102)

NCT ID: NCT02702102

Last Updated: 2025-03-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2025-03-18

Participant Flow

Participant milestones

Measure	11C-PBR28 PET Scans Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28. 11C-PBR28: Up to 20 millicuries
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	11C-PBR28 PET Scans n=5 Participants Elderly participants will receive one IV injection of up to 20 millicuries of 11C-PBR28.
Age, Customized 50-59 years old	0 participants n=5 Participants
Age, Customized 60-69 years old	1 participants n=5 Participants
Age, Customized 70-79 years old	3 participants n=5 Participants
Age, Customized 80-89 years old	1 participants n=5 Participants
Age, Customized 90-99 years old	0 participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	11C-PBR28 PET Scans n=5 Participants Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28. 11C-PBR28: Up to 20 millicuries
Absolute 11C-PBR28 Binding (Total Distribution Volume Corrected for Free Fraction in Plasma)	0.15 kBq·cm-3 / kBq·mL-1 Standard Deviation 0.17

SECONDARY outcome

Timeframe: 1 year

Standardized Uptake Value Ratio (SUVR) measured on PET scan using 11C-PBR28.

Outcome measures

Measure	11C-PBR28 PET Scans n=5 Participants Participants will receive one IV injection of up to 20 millicuries of 11C-PBR28. 11C-PBR28: Up to 20 millicuries
Relative 11C-PBR28 Binding	0.94 SUV ratio Standard Deviation 0.20

Adverse Events

11C-PBR28 PET Scans

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Kreisl, MD

Columbia University

Phone: 212-305-9194

Email: wck2107@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place