Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease
NCT04576793 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-07-03
Summary
The purpose of this study is to determine how inflammation is related to other changes in the brain that occur during the progression of Alzheimer's disease. The investigators are also studying how inflammation is related to the symptoms that first occur in patients with Alzheimer's disease (AD). For this reason, the investigators are asking people with different versions of Alzheimer's disease and/or other related dementias to participate. This includes patients with:
* Mild Cognitive Impairment
* Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties
* Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties
* Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties
* The investigators are also enrolling older adults with normal visual, language, and memory function.
Conditions
- Alzheimer Disease
Interventions
- DRUG
-
11C-ER176
11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. 11C-ER176 will be administered at activity up to 20 millicurie (mCi) per injection.
- DRUG
-
18F-MK6240
MK-6240 measures a protein called in the brain. MK-6240 is experimental but has been used in several human studies before and has been proven to accurately measure tau in the brain.
- DRUG
-
18F-Florbetaben
Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. florbetaben measures amyloid in the brain.
- PROCEDURE
-
Lumbar Puncture
Inflammation can also be measured by looking at certain proteins in the spinal fluid. In order to measure these proteins in the spinal fluid, the investigators will perform a lumbar puncture (spinal tap).
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH -
Patrick Lao
lead OTHER
Principal Investigators
-
Patrick J. Lao, PhD · Columbia University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-11-17
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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