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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 below
Select...
I do not have cognitive impairment or specific Alzheimer's disease.
Select...
I am 50 years old or older.

ADVISe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

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

Find a Location

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
1,671 Previous Clinical Trials
28,016,963 Total Patients Enrolled

Media Library

11C-ER176 Clinical Trial Eligibility Overview. Trial Name: NCT04576793 — Phase 2
Alzheimer's Disease Research Study Groups: Cognitive impairment, No cognitive impairment
Alzheimer's Disease Clinical Trial 2023: 11C-ER176 Highlights & Side Effects. Trial Name: NCT04576793 — Phase 2
11C-ER176 2023 Treatment Timeline for Medical Study. Trial Name: NCT04576793 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has 11C-ER176 been granted clearance by the Food & Drug Administration?

"There is limited evidence that 11C-ER176 can be safely administered, so it achieved a score of 2."

Answered by AI

Are there any prior examinations that have explored the efficacy of 11C-ER176?

"Presently, there exist 7 ongoing trials for 11C-ER176 with none reaching the final Stage 3. These clinical experiments are scattered across 9 locations primarily centered in Philadelphia, Pennsylvania."

Answered by AI

Is there an opportunity to join this research endeavor?

"This clinical trial seeks to recruit 100 individuals between the ages of 50 and 75 who have been diagnosed with Alzheimer's. To be eligible, candidates must not demonstrate any signs of cognitive impairment or fulfil established criteria for amnestic Alzheimer’s disease, posterior cortical atrophy, or logopenic variant primary progressive aphasia; possess both written and oral fluency in English; appear likely to comply with study protocol as judged by principal investigator (PI); hold at least a Clinical Dementia Rating scale score of 0.5 upon enrollment if they are patients, while controls need to achieve an overall score of zero; appoint a surrogate decision"

Answered by AI

How many participants are currently enrolled in this clinical trial?

"Affirmative. Per the information on clinicaltrials.gov, this experiment is actively recruiting participants and was initially posted on November 17th 2020 and most recently updated September 16th 2022. The research endeavours to recruit 100 people across a single site."

Answered by AI

Are there currently any vacancies in this trial?

"The information on clinicaltrials.gov details that this medical experiment is presently in pursuit of subjects. This trial was first registered on November 17th 2020 and its most recent update was posted September 16th 2022."

Answered by AI

Are participants of a certain age being excluded from this clinical investigation?

"This medical study can only be participated in by those aged between 50 to 75 years old. However, there are alternative studies accessible for both under 18s and over 65s - 23 trials and 543 trials respectively."

Answered by AI

Is this an unprecedented clinical trial?

"Currently, 7 clinical trials involving 11C-ER176 are active in 3 cities and 2 countries. The earliest trial of the medication was administered by Bayer back in 2010 with 161 participants taking part before reaching its endpoint. Since then, 16 further studies have been conducted."

Answered by AI
~24 spots leftby May 2025