Discovery and Validation of Genetic Variants Affecting Microglial Activation in Alzheimer's Disease (NCT04840979) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Discovery and Validation of Genetic Variants Affecting Microglial Activation in Alzheimer's Disease
United States107 participantsStarted 2021-05-11
Plain-language summary
The primary objectives are to validate that a previously identified gene variant influences the proportion of activated microglia (PAM) and the amount of TSPO binding on PET imaging, to identify novel loci that influence PAM and TSPO PET, and to understand the functional consequences of gene variants that drive microglial activation in Alzheimer's disease.
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 older at time of study entry.
. Meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or Alzheimer's disease, or b) have no cognitive impairment, based on history, exam, and neuropsychological testing.
. 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 must have AD biomarker previously obtained for research or clinical purposes or undergo a 18F-florbetaben PET scan during the screening process. Patients must have positive amyloid PET scan or CSF results consistent with AD. Controls must have a negative amyloid PET scan or CSF results not consistent with AD.
. Self-identify as white, non-Hispanic or Latino
. Subjects must be ableto provide informed consent
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.
What they're measuring
1
Correlation between the chromosome 1 variant (rs2997325) and TSPO binding
Timeframe: Up to 1 year
2
Number of variants discovered in genome-wide association study (GWAS) that influence TSPO binding
. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
Exclusion criteria
. Past or present history of certain brain disorders other than MCI or AD.
. Certain significant 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.
. Participation in the last year in a clinical trial for a disease modifying drug for AD.
. Inability to have a catheter in subject's vein for the injection of radioligand.
. Inability to have blood drawn from subject's veins.