Completed

Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.

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What is being tested

Flortaucipir F18

+ Brain PET scan

DrugProcedure
Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

Over 50 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 1
Interventional
Study Start: November 2013
See protocol details

Summary

Principal SponsorAvid Radiopharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleTest-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
NCT01992380
Principal SponsorAvid Radiopharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

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.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Healthy males or females 50 years or older with no evidence of cognitive impairment

Group II

Experimental
Subjects 50 years or older with mild cognitive impairment (MCI)

Group III

Experimental
Subjects 50 years or older with probable Alzheimer's Disease (AD)

Study 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

Suspended

Research Site

Newport Beach, United StatesOpen Research Site in Google Maps
Suspended

Research Site

New Haven, United States
Completed2 Study Centers