Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease (NCT04576793) | Clinical Trial Compass
RecruitingPhase 2
Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease
United States100 participantsStarted 2020-11-17
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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, exam, neuropsychological testing, brain MRI, and consensus diagnosis.
. 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.
. Subjects 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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 subjects above the allowable limits.
. Exact medication exclusions are up to the discretion of the PI in consultation with the MD liaison.