Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
Flortaucipir F18
+ Brain PET scan
Alzheimer Disease+6
+ Mental Disorders
+ Brain Diseases
Diagnostic Study
Summary
Study start date: November 13, 2013
Actual date on which the first participant was enrolled.This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Healthy Volunteers * Male or female subjects ≥ 50 years of age * Mini-mental state examination (MMSE) ≥ 29 * MCI Subjects * Male or female subjects ≥ 50 years of age * MMSE ≥ 24 * Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD * Have a study partner that can report on subject's activities of daily living * Probable AD Subjects * Male or female subjects ≥ 50 years of age * MMSE \> 10 * Meet clinical criteria for probable AD based on the NIA-AA working group's diagnostic guidelines for AD * Have a study partner that can report on subject's activities of daily living Exclusion Criteria: * Current clinically significant psychiatric disease * Evidence of structural brain abnormalities * Evidence of dementing illness other than AD * Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes * Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer * History of alcohol or substance abuse or dependence * Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception * Have received or participated in a trial with investigational medications in the past 30 days * have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Research Site
New Haven, United States