Tau Tracer Comparison in Healthy Controls and Alzheimer's Disease Patients

Withdrawn before enrolling · Not applicable

Conditions studied: Healthy, Alzheimer Disease

In brief

The primary objective of this study is to identify a new radioligand for imaging of tauopathy in Alzheimer's disease through direct comparisons of two potential candidates, \[18F\]RO-948 (formerly known as \[18F\]6958948) and \[18F\]MK-6240, and demonstration of the candidates' absence of off-target binding.

Key facts

Study ID

NCT03939780

Run by

Johns Hopkins University

People needed

0

Starts

2020-01-01

Expected to finish

2023-04-01

Last updated by the study team

2020-02-11

Who can join

Age: 50 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• History or presence of a neurological diagnosis other than AD that may influence the outcome or analysis of the scan results examples include but are not limited to stroke, traumatic brain injury, space occupying lesions, non-Alzheimer's tauopathies, and Parkinson's disease.
• Subjects with a medical history that includes known autosomal dominant AD mutations in amyloid precursor protein (APP) or presenilin (PS) 1, PS 2 or mutations in genes that cause other types of autosomal dominant familial dementia, e.g., microtubule-associated protein tau (MAPT)
• History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or central nervous system (CNS) disease or other medical conditions that are not well controlled, may put the subject at risk, could interfere with the objectives of the study, or make the subject unsuitable for participation in the study for any other reason in the opinion of the principal investigator.
• Clinically relevant pathological findings in physical examination, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the study.
• Known history of clinically significant infectious disease including AIDS or serological indication of acute or chronic hepatitis B or C or HIV infection.
• Women of childbearing potential must not be pregnant, or nursing and serum human chorionic gonadotropin (HCG) must be negative at the time of Screening Visit, and urine HCG must be negative on all subsequent visits.
• Loss or donation of more than 450 mL blood in the 4 months before screening or donation of plasma within 14 days of screening.
• Current symptoms of allergy and or severe allergy to drugs in medical history.
• History of drug or alcohol abuse or positive result from urine screen for drugs of abuse AD subjects on prescribed narcotics medications will not be excluded if urine drug screen is positive for the documented narcotic drugs.
• Have received an investigational medication within the last 3 months or 5 elimination half-life, whichever is longer, prior to administration of the radiotracer.
• Has had or is planning to have exposure to ionizing radiation that in combination with the study related tracer administrations and scanning procedures would result in a cumulative exposure that exceeds recommended exposure limits.
• Contraindications of MRI
• History of, or suffers from, claustrophobia or feels that he or she will be unable to lie still on their back in the MRI or PET scanner.

Where it is running

• John Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.