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Brain Inflammation Imaging for Alzheimer's Disease (ADVISe Trial)

Phase 2

Recruiting

Led By Patrick J. Lao, PhD

Research Sponsored by Patrick Lao

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

Must not have

Taking immunosuppressive medication

Past or present history of a brain disorder other than Alzheimer's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have cognitive impairment or specific Alzheimer's disease.

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication that suppresses my immune system.

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I have a history of a brain disorder that is not Alzheimer's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

11C-ER176 Standardized Uptake Value Ratio

18F-MK6240 Standardized Uptake Value Ratio

Awards & Highlights

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive impairmentExperimental Treatment4 Interventions

* Mild Cognitive Impairment * 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

2020

Completed Phase 2

~250

Florbetaben (18F)

FDA approved