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New treatment option for Alzheimer Disease
Official title Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease
ClinicalTrials.gov ID: NCT04576793
What this study is testing
What is 11C-ER176?
11C-ER176 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for alzheimer disease.
Also referred to as [11C] ER176.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age 50 and over at time of screening.
- At screening, must have no cognitive impairment, or meet criteria for amnestic Alzheimer's disease, posterior cortical atrophy, or logopenic variant...
- Patients must have Clinical Dementia Rating scale score of 0.5 or 1 at enrollment. Controls must have Clinical Dementia Rating scale score of 0 at...
- people unable to provide informed consent must have a surrogate decision maker.
- Written and oral fluency in English or Spanish.
You likely can't join if
- Past or present history of a brain disorder other than Alzheimer's disease (including presence of cortical infarct on MRI even in absence of clinical...
- Serious medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy...
- Contraindication to MRI scanning.
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- Exposure to research related radiation in the past year that, when combined with this study, would place people above the allowable limits.
- Exact medication exclusions are up to the discretion of the PI in consultation with the MD liaison.
See the full eligibility criteria
- Age 50 and over at time of screening.
- At screening, must have no cognitive impairment, or meet criteria for amnestic Alzheimer's disease, posterior cortical atrophy, or logopenic variant primary progressive aphasia. Diagnoses will be made based on history...
- Patients must have Clinical Dementia Rating scale score of 0.5 or 1 at enrollment. Controls must have Clinical Dementia Rating scale score of 0 at enrollment.
- people unable to provide informed consent must have a surrogate decision maker.
- Written and oral fluency in English or Spanish.
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
- In the opinion of the PI, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
- Past or present history of a brain disorder other than Alzheimer's disease (including presence of cortical infarct on MRI even in absence of clinical stroke).
- Serious medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
- Contraindication to MRI scanning.
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- Exposure to research related radiation in the past year that, when combined with this study, would place people above the allowable limits.
- Exact medication exclusions are up to the discretion of the PI in consultation with the MD liaison.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.