CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
11C-PBR28 +2 moredrug
Likely dose
11C-PBR28 up to 20 mCi per injection; 18F-Florbetaben up to 8.1 mCi per injectionAI-extracted
Key inclusion· 3
  • Age 60 or older
  • Amnestic mild cognitive impairment (single or mixed domain) or mild Alzheimer's disease with CDR 0.5-1, OR cognitively unimpaired with CDR 0
  • Able to tolerate MRI and PET scanner procedures including venous access
Key exclusion· 9
  • History of brain disorders other than MCI or Alzheimer's disease
  • Significant medical conditions making study procedures unsafe
  • Contraindication to MRI scanning
  • Conditions precluding scanner entry (morbid obesity, claustrophobia, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02831283
NCT02831283Phase 2Completed

Imaging Inflammation in Elders With Different Clinical and Biomarker Profiles of Alzheimer's Disease

Patrick Lao·interventional·Posted Jul 13, 2016·Updated Mar 5, 2025

In Brief

A Phase 2 clinical trial evaluating 11C-PBR28, 18F-Florbetaben, and 1 other intervention for Alzheimer's Disease. Completed, enrolled 60 participants across 1 site.

Detailed Summary

This study is being done to learn about inflammation and amyloid in Alzheimer's disease. A type of brain scan called a PET scan is used measure 1) inflammation and 2) abnormal accumulation of a the amount of a certain protein fragment called beta-amyloid (plaques) in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and do tests to measure the participants' memory and thinking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 13, 2016
Enrollment StartJun 1, 2016
Primary CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 10.0 years ago

Interventions

11C-PBR28drug

11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation. 11C-PBR28 has previously been administered in humans. 11C-PBR28 will be administered at activity of up to 20 mCi per injection.

18F-Florbetabendrug

18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease. 18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.

Lumbar puncture (optional)procedure

Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.