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Genetic Variants and Microglial Activation Imaging for Alzheimer's Disease
Phase 2
Recruiting
Led By William Kreisl, MD
Research Sponsored by William Charles Kreisl
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 50 and older at time of study entry
Meet criteria for amnestic mild cognitive impairment (single or mixed domain) or Alzheimer's disease, or have no cognitive impairment based on history, exam, and neuropsychological testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is looking at whether a gene variant affects microglial activation and TSPO binding in Alzheimer's disease, and if so, what the consequences are.
Who is the study for?
This trial is for white, non-Hispanic or Latino individuals aged 50+, fluent in English, with mild Alzheimer's or no cognitive impairment. Participants must have a certain Clinical Dementia Rating and be able to consent. They need prior AD biomarker results or will undergo a PET scan. Exclusions include severe medical conditions, MRI contraindications, recent excessive research radiation exposure, chronic inflammatory/infectious diseases, and other brain disorders.Check my eligibility
What is being tested?
The study tests how gene variants affect microglial activation in Alzheimer's using PET imaging agents: 11C-ER176 and 18F-florbetaben. It aims to validate known genetic influences on activated microglia proportion and discover new gene loci related to this process while assessing the functional impact of these variants.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions at the injection site from radioligands used for PET scans (like redness or swelling), discomfort from blood draws, and typical risks associated with undergoing PET scans such as exposure to low levels of radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
I have been diagnosed with mild cognitive impairment or Alzheimer's, or I have no cognitive issues.
Select...
I have had a test showing amyloid presence consistent with Alzheimer's disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Correlation between the chromosome 1 variant (rs2997325) and TSPO binding
Number of variants discovered in genome-wide association study (GWAS) that influence TSPO binding
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive ImpairmentExperimental Treatment2 Interventions
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.
Group II: No Cognitive ImpairmentActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
11C-ER176
2018
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
William Charles KreislLead Sponsor
6 Previous Clinical Trials
306 Total Patients Enrolled
Edward D Huey, MDLead Sponsor
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,009 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 50 years old or older.I have a history of brain disorders other than mild cognitive impairment or Alzheimer's.You have participated in a clinical trial for a drug that changes the course of Alzheimer's disease in the past year.I have a chronic inflammatory or infectious disease like MS, IBD, RA, psoriasis, lupus, or HIV.I have been diagnosed with mild cognitive impairment or Alzheimer's, or I have no cognitive issues.I have had a test showing amyloid presence consistent with Alzheimer's disease.I am currently on blood thinners or drugs that affect my immune system.You are unable to have blood taken from your veins.Patients must show early signs of dementia, while controls must not show any signs of dementia.You cannot have an MRI scan for medical reasons.I do not have uncontrolled epilepsy or multiple serious injuries.You cannot have a tube inserted into your vein for the injection of the radioligand.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Impairment
- Group 2: No Cognitive Impairment
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What safety measures should be taken when administering 11C-ER176?
"We have rated 11C-ER176 a 2 on our safety scale, as Phase 2 trials typically provide evidence for the former but not the latter."
Answered by AI
How many people can participate in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research study posted on May 11th 2021 is currently recruiting participants. There are 250 spots at a single site for potential patients who meet the criteria."
Answered by AI
Is enrollment open to new participants in this research protocol?
"Per clinicaltrials.gov, this medical research is still in need of participants. It was made public on May 11th 2021 and underwent its most recent update on September 15th 2022."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How long do screening visits take?
PatientReceived 2+ prior treatments
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