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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
Female subjects must be either surgically sterile or post-menopausal for at least 1 year or, Women of childbearing potential must commit to use a barrier contraception method for the duration of the study in addition to either an intra uterine device or hormonal contraception started at least 1 month prior to the first dose of radiotracer and until follow-up
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 37-44 days
Awards & highlights
No Placebo-Only Group

Study 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.Check my eligibility
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.See study design
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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I am a woman who cannot become pregnant or will use two forms of birth control during the study.
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I am a male and will use effective birth control and not donate sperm during the study.
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I have given or my legal representative has given consent for me to participate.
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My current medications and their doses have been stable for at least 4 weeks.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,921 Previous Clinical Trials
2,293,879 Total Patients Enrolled
Roche Pharma AGIndustry Sponsor
408 Previous Clinical Trials
395,846 Total Patients Enrolled
Dean F WongPrincipal InvestigatorHead Researcher/Professor of Radiology

Media Library

18F-MK6240 Clinical Trial Eligibility Overview. Trial Name: NCT05464368 — Phase 1
Alzheimer's Disease Research Study Groups: Cohort 2: (A-; CDR=0; OC), Cohort 3: (A+; CDR = 0, .5, 1; AD), Cohort 1: (A+; CDR = .5, 1; AD)
Alzheimer's Disease Clinical Trial 2023: 18F-MK6240 Highlights & Side Effects. Trial Name: NCT05464368 — Phase 1
18F-MK6240 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464368 — Phase 1

Frequently Asked Questions

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

How may I gain admittance to this clinical research study?

"This clinical trial requires 38 volunteers aged between 50 and 100 years old who have been clinically diagnosed with Alzheimer's disease. Participants must satisfy the following criteria: male or female within age range, BMI 18-32 kg per m2, body weight less than 300 pounds, normal cognition for older individuals (CDR = 0), positive florbetapiro, amyloid BB BM or CSF biomarkers consistent with AD diagnosis, reliable companion to all visits able to answer questions about subject, able to tolerate PET scan procedures and tracer administration safely without alteration of concomitant medication use/dose in 4 weeks prior to study start. Female"

Answered by AI

Can you provide details regarding the safety of 18F-MK6240 for individuals receiving treatment?

"Our team at Power judged the safety of 18F-MK6240 to be a 1 on our scale, as this is an early stage trial with limited evidence supporting both its efficacy and security."

Answered by AI

Does this research initiative accept participants younger than 40 years of age?

"This medical trial is inviting seniors aged 50 or above and under 100 to participate."

Answered by AI

Is this project currently recruiting participants?

"Affirmative. Clinicaltrials.gov data reveals that this trial is actively seeking patients, initially posted on August 1st 2022 and most recently updated on July 14th of the same year. 38 participants will be accepted from a single clinical site."

Answered by AI

How many participants have enrolled in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial which was first published on August 1st 2022 is currently enrolling volunteers. 38 participants are needed from a single location."

Answered by AI
~25 spots leftby Jun 2027