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Eligibility
for people ages 20 years and up
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a cross-sectional and longitudinal study that will evaluate imaging characteristics of 18F-AV-1451 in cognitively healthy volunteers, mild cognitive impairment (MCI) and Alzheimer's disease (AD) subjects.

Official Title

An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease

Keywords

Alzheimer's Disease

Eligibility

You can join if…

Open to people ages 20 years and up

Exploratory Cognitively Healthy Subjects

  • ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age
  • Mini-mental state examination (MMSE) ≥ 29
  • No significant history of cognitive impairment

    Exploratory MCI 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

    Exploratory AD Subjects

  • ≥ 50 years of age
  • MMSE> 10
  • Have possible or 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

    Confirmatory Subjects

  • ≥ 50 years of age
  • MMSE ≥ 20 and ≤ 27
  • Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause
  • Have a study partner that can report on subject's activities of daily living

You CAN'T join if...

  • Current clinically significant psychiatric disease
  • Evidence of structural brain abnormalities
  • History of moderate or severe traumatic brain injury
  • 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.

Locations

  • UC San Francisco
    San Francisco, California, 94158, United States
  • UC Davis
    Sacramento, California, 95817, United States
  • Norther California PET Imaging Center
    Sacramento, California, 95816, United States
  • Neurological Research Institute
    Santa Monica, California, 90404, United States
  • Hoag Memorial
    Newport Beach, California, 92663, United States
  • UC Irvine
    Irvine, California, 92697, United States
  • Las Vegas Radiology
    Las Vegas, Nevada, 89147, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avid Radiopharmaceuticals
ID
NCT02016560
Phase
Phase 2/3
Lead Scientist
Gil Rabinovici
Study Type
Interventional
Last Updated
April 1, 2017