Active — Not RecruitingPhase 1

R21 Roche: 3-Way Tau Tracers in AD

United States38 participantsStarted 2023-02-01

Plain-language 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.

Who can participate

Age range50 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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. Male subjects and their partners of childbearing potential must agree to use an effective method of contraception and will not donate sperm during the study. Barrier method must include use of a spermicide. * Subjects who sign an IRB approved informed consent prior to any study procedures. Subjects deemed incapable of informed consent must have informed consent provided by a legally authorized representative. For AD subjects, capacity for consent will be determined using the Alzheimer Disease Research Center's questions * 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. * If subjects are on any concomitant medication, the indication and dosage of these medicines should be stable for at least 4 weeks prior to study start with the expectation that no relevant changes in use or dose will occur throughout the trial. * Body mass index BMI between 18 and 32 kg per m2, Body weight less than 300 pounds * O…

What they're measuring

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

Timeframe: 37-44 days

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.

Timeframe: 37-44 days

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.

Timeframe: 37-44 days

Trial details

NCT IDNCT05464368

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Alzheimer Disease trials

Plain-language summary

Who can participate

Age range50 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 37-44 days