Cohort 2: (A-; CDR=0; OC) for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Alzheimer Disease
18F-MK6240 - Drug
Eligibility
18+
All Sexes
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Study Summary

This is an open label study to compare three new generation TAU radioligands, 18F-RO948 (formerly known as 18F-6958948), 18F-MK6240, and [18F]GTP1for imaging of taupathy and demonstrate their absence of off-target binding in patients with Alzheimer disease (AD) and older healthy controls (OC). The study will directly compare AD and OC with these three next-generation TAU radioligands and compare each of them with historical data of the current most widely used first generation radioligand, 18F-AV1451. Upto38 (30 AD (Amyloid +)and 8 OC (Amyloid -), matched for age and sex with A+ subjects) male and female subjects aged 50-100 will be enrolled in this study protocol: up to 8 for Cohort 1, up to 8 for Cohort 2, and up to 22 for Cohort 3. The study consists of three cohorts: Cohort 1: Up to8 AD subjects (A+; CDR 0.5 and 1)will receive two PET scans in random order, with receiving either18F-RO948 or18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 2:Up to8 OC (A-; CDR=0)subjects will receive two PET scans in random order, with receiving either18F-RO948or 18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 3:Up to 22 (A+; CDR = 0, .5 and 1) subjects will receive three PET scans in random order, with receiving 18F-RO94818F-MK6240 or18F-GTP1at the first scan. Efforts will be made to include about 1/3 CDR = 0, 1/3 CDR .5, and 1/3 CDR 1 in Cohort 3.

Treatment Effectiveness

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 37-44 days

37-44 days
Amyloid positivity of patients with Alzheimer disease or positive memory or thinking problem CDR assessment compared to amyloid negative older healthy controls.
Correlation between imaging capability of 18F-RO948, 18F-MK6240 and 18F-GTP1 and amyloid positivity of patients with Alzheimer disease or positive memory or thinking problem CDR assessment compared to amyloid negative older healthy controls.
Imaging capability of 18F-RO948, 18F-MK6240 and 18F-GTP1 in patients with Alzheimer disease or positive memory or thinking problem CDR assessment, and amyloid negative older healthy controls, as compared to 18F-AV1451.

Trial Safety

Trial Design

3 Treatment Groups

Cohort 2: (A-; CDR=0; OC)
1 of 3
Cohort 1: (A+; CDR = .5, 1; AD)
1 of 3
Cohort 3: (A+; CDR = 0, .5, 1; AD)
1 of 3
Experimental Treatment

38 Total Participants · 3 Treatment Groups

Primary Treatment: Cohort 2: (A-; CDR=0; OC) · No Placebo Group · Phase 1

Cohort 2: (A-; CDR=0; OC)Experimental Group · 3 Interventions: 18F-MK6240, 18F-GTP1, [18F]RO-948 · Intervention Types: Drug, Drug, Drug
Cohort 1: (A+; CDR = .5, 1; AD)Experimental Group · 3 Interventions: 18F-MK6240, 18F-GTP1, [18F]RO-948 · Intervention Types: Drug, Drug, Drug
Cohort 3: (A+; CDR = 0, .5, 1; AD)Experimental Group · 3 Interventions: 18F-MK6240, 18F-GTP1, [18F]RO-948 · Intervention Types: Drug, Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 37-44 days
Closest Location: Washington University School of Medicine · Saint Louis, MO
Photo of washington university school of medicine  1Photo of washington university school of medicine  2Photo of washington university school of medicine  3
2004First Recorded Clinical Trial
31 TrialsResearching Alzheimer Disease
1465 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects must be either surgically sterile or post-menopausal for at least 1 year or, Women of child bearing 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
Subjects who sign an IRB approved informed consent prior to any study procedures
Older controls must have normal cognitive function, including a normal CDR = 0 as judged by the investigator for OC.
Subjects who in the opinion of the investigator based on medical history and physical exam can tolerate the PET scan procedures, and can safely tolerate tracer administration and the scanning procedures.
Subjects should be on the same concomitant medication for at least 4 weeks prior to study start.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.