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

Who is this study for? Older adult patients with Alzheimer's Disease
What treatments are being studied? 11C ER176
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

• 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

• Written and oral fluency in English

• Able to participate in all scheduled evaluations and to complete all required tests and procedures.

• 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.

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Galen Ziaggi
gfz2102@cumc.columbia.edu
212-305-9079
Backup
Elena Golub
eg2972@cumc.columbia.edu
212-305-9079
Time Frame
Start Date: 2021-05-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 250
Treatments
Experimental: Cognitive Impairment
Subjects diagnosed with Alzheimer's disease (AD) or mild cognitive impairment (MCI) will have one PET scan with 11C-ER176, with arterial sampling. If the subject lacks known AD-biomarkers, they may undergo a 18F-florbetaben PET scan prior to the 11C-ER176 PET scan. Genome-wide genetic analysis will be performed. Participants will undergo an annual clinical evaluation and blood sample collection for 5 years to establish the trajectory of AD-related serum biomarkers and syndromic diagnoses.
Active_comparator: No Cognitive Impairment
Healthy volunteers who are cognitively normal will have one PET scan with 11C-ER176, with arterial sampling. If the subject lacks known AD-biomarkers, they may undergo an 18F-florbetaben PET scan prior to the 11C-ER176 PET scan. Genome-wide genetic analysis will be performed. Participants will undergo an annual clinical evaluation and blood sample collection for 5 years to establish the trajectory of AD-related serum biomarkers and syndromic diagnoses.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Institute on Aging (NIA)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials