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Tau Radioligand Imaging for Alzheimer's Disease

Phase 1

Recruiting

Led By Dean F Wong

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female subjects 50 to 100 years of age

Body mass index BMI between 18 and 32 kg per m2, Body weight less than 300 pounds

Must not have

Subjects with a medical history that includes known autosomal dominant AD mutations in amyloid precursor protein APP or presenilin PS1, PS2 or mutations in genes that cause other types of autosomal dominant familial dementia, e.g., tau MAPT

Known history of clinically significant infectious disease including AIDS or serological indication of acute or chronic hepatitis B or C or HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 37-44 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing three new generation tau radioligands (18F-RO948, 18F-MK6240, and [18F]GTP1) to compare their ability to image tauopathy and demonstrate their lack of off-target binding in patients with Alzheimer disease and older healthy controls.

Who is the study for?

This trial is for men and women aged 50-100 with probable Alzheimer's Disease (AD) who can undergo PET scans. AD participants must have a positive amyloid test, while older controls need normal cognitive function. Women of childbearing age must use contraception, and all subjects should be able to consent or have a representative do so.

What is being tested?

The study tests three new TAU radioligands (18F-MK6240, [18F]RO-948, 18F-GTP1) against the first-generation radioligand in imaging tauopathy in AD patients and healthy controls. Participants will receive up to three PET scans with these tracers to compare their effectiveness.

What are the potential side effects?

Potential side effects are not specified but may include reactions related to the PET scan procedure or discomfort from lying still during scanning. The safety profile of the radioligands will also be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

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I am between 50 and 100 years old.

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My BMI is between 18 and 32, and I weigh less than 300 pounds.

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My cognitive function is normal, as confirmed by a doctor.

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I have been diagnosed with Alzheimer's disease, with mild to moderate symptoms confirmed by tests.

Exclusion Criteria

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

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I have a genetic mutation linked to familial dementia.

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I do not have a history of significant infectious diseases like AIDS or hepatitis.

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I haven't lost or donated more than 450 mL of blood in the last 4 months, nor have I donated plasma in the last 14 days. I also don't have a bleeding disorder or take blood thinners.

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I will be exposed to a high level of radiation due to tests and treatments.

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I have not completed 2 COVID-19 vaccine shots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 37-44 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~37-44 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 37-44 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Amyloid positivity of patients with Alzheimer disease or positive memory or thinking problem CDR assessment compared to amyloid negative older healthy controls.

Alzheimer's Disease

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3: (A+; CDR = 0, .5, 1; AD)Experimental Treatment3 Interventions

Unblinded and randomized to receive 18F-RO948or 18F-MK6240 or \[18F\]GTP1for PET Scan #1. PET scan #2 will be 18F-RO948or 18F-MK6240 or \[18F\]GTP1NOT received in PET scan #1. PET scan # 3 will be 18F-RO948or 18F-MK6240 or \[18F\]GTP1NOT received in PET scan #1 or #2. Efforts will be made to include about 1/3 CDR = 0; 1/3 CDR = .5; 1/3 CDR = 1 in Cohort 3. Efforts will also be made to completethe study with about equal numbers of subjects whose PET scan #1 start with each of the three tracers.

Group II: Cohort 2: (A-; CDR=0; OC)Experimental Treatment3 Interventions

Unblinded and randomized to receive either 18F-RO948or 18F-MK6240 for PET Scan #1. PET scan #2 will be either 18F-RO948or 18F-MK6240 NOT received in PET scan#1.If a 3rdPET scan occurs, this third scan will always be \[18F\]GTP1.

Group III: Cohort 1: (A+; CDR = .5, 1; AD)Experimental Treatment3 Interventions

Unblinded and randomized to receive either 18F-RO948or 18F-MK6240 for PET Scan #1. PET scan #2 will be either 18F-RO948or 18F-MK6240 NOT received in PET scan #1. If a 3rdPET scanoccurs,this third scanwill always be \[18F\]GTP1.

0 / 9Eligibility criteria met