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Brain Inflammation Imaging for Alzheimer's Disease (ADVISe Trial)
Phase 2
Recruiting
Led By William C. 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
Must have no cognitive impairment, or meet criteria for specific types of Alzheimer's disease
Age 50 and over at time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
ADVISe Trial Summary
This trial is studying inflammation in the brain in people with Alzheimer's disease to see how it is related to changes in the brain and symptoms.
Who is the study for?
This trial is for adults over 50 with or without Alzheimer's disease (AD), including those with vision or language difficulties, and typical memory issues. Participants must be fluent in English, able to give consent (or have a surrogate decision maker), and likely to follow the study plan. People with serious medical conditions, recent excessive research-related radiation exposure, immune system-suppressing medication use, other brain disorders besides AD, or MRI contraindications cannot join.Check my eligibility
What is being tested?
The study aims to understand how brain inflammation relates to Alzheimer's progression and symptoms by using imaging agents like 11C-ER176 and 18F-MK6240 PET scans along with an amyloid plaque detector called 18F-Florbetaben. It also involves a lumbar puncture procedure to examine spinal fluid.See study design
What are the potential side effects?
Possible side effects include discomfort from the lumbar puncture such as back pain or headache; allergic reactions or irritation at the injection site from imaging agents; temporary redness or swelling; and risks associated with PET scans like minimal radiation exposure.
ADVISe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have cognitive impairment or specific Alzheimer's disease.
Select...
I am 50 years old or older.
ADVISe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
11C-ER176 Standardized Uptake Value Ratio
18F-MK6240 Standardized Uptake Value Ratio
ADVISe Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive impairmentExperimental Treatment4 Interventions
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
Group II: No cognitive impairmentActive Control4 Interventions
Healthy controls
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
11C-ER176
2018
Completed Phase 2
~10
Florbetaben (18F)
FDA approved
Lumbar Puncture
2016
Completed Phase 3
~510
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Who is running the clinical trial?
William Charles KreislLead Sponsor
6 Previous Clinical Trials
456 Total Patients Enrolled
James M Noble, MD, MS, CPH, FAANLead Sponsor
2 Previous Clinical Trials
175 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,699 Previous Clinical Trials
28,032,749 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have cognitive impairment or specific Alzheimer's disease.I am 50 years old or older.You have been in a clinical trial for a drug that changes how a disease affects your body in the past year.You have a specific score on a test that shows your level of memory and thinking problems.I am currently taking medication that suppresses my immune system.You cannot have an MRI scan for medical reasons.I have a history of a brain disorder that is not Alzheimer's disease.
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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
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