Discovery and Validation of Genetic Variants Affecting Microglial Activation in Alzheimer's Disease

Description

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.

Conditions

Alzheimer Disease

Study Overview

Study Details

Study overview

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.

Discovery and Validation of Genetic Variants Affecting Microglial Activation in Alzheimer's Disease With 11C-ER176

Discovery and Validation of Genetic Variants Affecting Microglial Activation in Alzheimer's Disease

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age 50 and older at time of study entry.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 5. Self-identify as white, non-Hispanic or Latino
  • 6. Subjects must be ableto provide informed consent
  • 7. Written and oral fluency in English
  • 8. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
  • 9. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
  • 1. Past or present history of certain brain disorders other than MCI or AD.
  • 2. Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
  • 3. Contraindication to MRI scanning
  • 4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
  • 5. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
  • 6. Participation in the last year in a clinical trial for a disease modifying drug for AD.
  • 7. Inability to have a catheter in subject's vein for the injection of radioligand.
  • 8. Inability to have blood drawn from subject's veins.
  • 9. Taking anticoagulant (e.g., warfarin) or immunosuppressive/immunomodulatory medication. Nonsteroidal anti-inflammatory drugs (NSAIDs) are not exclusionary. Use of steroids in the 30 days preceding the PET scan.
  • 10. Having a diagnosis of a chronic inflammatory disease (for example, multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis, psoriasis, systemic lupus erythematosus) or a chronic infectious disease such as H.I.V.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Columbia University,

Philip De Jager, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2026-12