Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03089918 : A Study to Investigate the Regional Brain Kinetics of Brain Drug Transporters Using P-glycoprotein and Breast Cancer Resistance Protein Substrates and by Using the Positron Emission Tomography Ligand 11C-JNJ-63779586 in the Human Brain
PhasePhase 1
AgesMin: 18 Years Max: 85 Years
Eligibility
Inclusion Criteria:

Part A

- Healthy men between 18 and 55 years of age, inclusive

- Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) ²,
inclusive, and a body weight of not less than 50 kilogram (kg) Part B

- Men or women with mild Alzheimer's Disease (AD), age- and gender-matched control
participants, between 55 and 85 years of age, inclusive

- BMI between 18 and 35 kg/m^2, inclusive, and a body weight of not less than 50 kg

- Mild AD participants will be amyloid positive and have a mini-mental state examination
(MMSE) greater than or equal to (>=) 20. The matched control participants will be
amyloid negative and have a MMSE >= 26, respectively

Exclusion Criteria:

- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
abnormalities, significant pulmonary disease, including bronchospastic respiratory
disease, diabetes mellitus, hepatic or renal insufficiency (estimated glomerular
filtration rate [eGFR] within the screening period of less than 60 milliLitre per
minute per 1.73 meter square [mL/min/1.73 m^2], thyroid disease, neurologic or
psychiatric disease, infection, or any other illness that the investigator considers
should exclude the participant or that could interfere with the interpretation of the
study results

- Clinically significant abnormal values for hematology, clinical chemistry, or
urinalysis at screening or at admission to the study center as deemed appropriate by
the investigator

- Participant has a clinically relevant abnormal physical- or neurological examination,
vital signs or 12-lead electrocardiogram (ECG)

- Participant has a history of epilepsy or fits or unexplained black-outs other than
vasovagal collapse within 10 years before screening

- Participant has past or planned exposure to ionizing radiation that in combination
with the planned administration with the study Positron Emission Tomography (PET)
ligand and Computerized Tomography (CT) scan would result in a cumulative exposure
that exceeds local recommended exposure limits
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03089918      |      Link to official Clinicaltrials.gov listing
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