CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 18 enrolled
Drug / intervention
LPSdrug
Likely dose
LPS 0.4 ng/kgAI-extracted
Key inclusion· 8
  • ✓Mild AD subjects meeting NIA-Alzheimer's Association core clinical criteria for probable AD
  • ✓Age 55-90 years
  • ✓MOCA score ≥17
  • ✓Biomarker evidence of AD via amyloid PET scan or CSF amyloid-beta measurement
Key exclusion· 21
  • ✕Significant neurologic disease other than probable AD (stroke, Parkinson's, brain tumor, seizure, MS, significant head trauma with deficits)
  • ✕Significant systemic disease (hepatic/heart/renal failure, COPD, active infection, autoimmune disease)
  • ✕MRI evidence of infection, infarction, focal lesions, multiple lacunes, or lacunes in critical memory structures
  • ✕Uncontrolled/insulin-dependent diabetes, uncorrected thyroid dysfunction, systemic cancer

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

Search/NCT04057807
NCT04057807Early Ph 1Completed
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PBR28 Brain Positron Emission Tomography Imaging With Lipopolysaccharide (LPS) Challenge for the Study of Microglia Function in Alzheimer's Disease

Yale University·interventional·Posted Aug 15, 2019·Updated Feb 5, 2024

In Brief

A Early Phase 1 clinical trial evaluating LPS for Alzheimer Disease. Completed, enrolled 18 participants across 1 site.

Detailed Summary

To examine the differences in the capacity to activate microglia in patients with Alzheimer's Disease (AD) compared to age-comparable cognitively normal subjects and younger healthy controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedAug 15, 2019
Enrollment StartApr 15, 2018
Primary CompletionJul 27, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.9 years ago

Interventions

LPSdrug

LPS (0.4 ng/kg)