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NCT03744312

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

Completed Phase 1, PHASE2 Results posted Last updated 17 April 2025
What this trial tests

Phase 1, PHASE2 trial testing 11C-ER176 in Alzheimer Disease in 9 participants. Completed in 20 July 2022.

Timeline
10 September 2018
Primary endpoint
20 July 2022
20 July 2022

Quick facts

Lead sponsorColumbia University
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment9
Start date10 September 2018
Primary completion20 July 2022
Estimated completion20 July 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Columbia University

Who can join

50 and older, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

11C-ER176 Total Distribution Volume Primary · Up to one year from baseline

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.

GroupValue95% CI
Cognitive Impairment6.273.03 – 8.8
No Cognitive Impairment9.329.32 – 9.32
11C-ER176 Standardized Uptake Value Ratio Secondary · Up to one year from baseline

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.

GroupValue95% CI
Cognitive Impairment1.191.10 – 1.38
No Cognitive Impairment1.221.22 – 1.22

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Recent advances in molecular pathways and therapeutic implications targeting neuroinflammation for Alzheimer's disease.
    Dhapola R, Hota SS, Sarma P, Bhattacharyya A, et al · · 2021 · cited 254× · PMID 34813026 · DOI 10.1007/s10787-021-00889-6
  2. PET Imaging of Neuroinflammation in Alzheimer's Disease.
    Zhou R, Ji B, Kong Y, Qin L, et al · · 2021 · cited 97× · PMID 34603323 · DOI 10.3389/fimmu.2021.739130
  3. Novel brain PET imaging agents: Strategies for imaging neuroinflammation in Alzheimer's disease and mild cognitive impairment.
    Huang J. · · 2022 · cited 5× · PMID 36211392 · DOI 10.3389/fimmu.2022.1010946

Verify or expand the search:

Other trials of 11C-ER176

Trials testing the same drug.

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other Columbia University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03744312.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing