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OpenTrials
Completed

NCT Number: NCT01890343

Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.

Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal volunteers and subjects with Alzheimer's disease (AD).

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

AD:

  • Male or female >= 50 years of age
  • Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
  • Have a caregiver who can report on their mental status and activities of daily living (ADL)
  • Give informed consent or have a caregiver give consent with subject assent.

FTD:

  • Male or female >= 45 years of age
  • Meet consensus criteria for FTD and have mild to moderate disease severity. Have a caregiver who can report on their mental status and ADL
  • Give informed consent or have a caregiver give consent with subject assent.

CN:

  • Male or female >= 45 years of age
  • Have and MMSE >= 29
  • Give informed consent

Exclusion criteria

  • Have a history or a current clinically significant neurologic disease (other than AD or FTD, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a diagnosis of mixed dementia
  • Evidence from MRI or other biomarkers that suggests an etiology of dementia other than AD or FTD, as applicable or in the case of CN subjects evidence indicating the presence of AD, FTD or other types of neurologic pathology
  • Have current clinically significant cardiovascular disease, screening ECG abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, cancer or infectious disease
  • Have a recent history of alcohol or substance abuse or dependence
  • Women of childbearing potential who are not permanently surgically sterile, or are not refraining from sexual activity while not using adequate contraception.
  • Require medications with a narrow therapeutic window, are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
  • Have ever participated in a study with an amyloid targeting agent
  • Have had a radiopharmaceutical imaging or treatment procedure within 7 days of the imaging, other than as defined in the protocol

Treatment and study plan

florbetapir 18F

Drug

Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

Other names: Florbetapir F 18, 18F-AV-45, Amyvid

18F-FDG

Drug

FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.

Other names: FDG, fluorodeoxyglucose (18F), fludeoxyglucose (18F)

Primary outcomes

  1. Qualitative Amyloid Image Assessment

    Time frame: 50-60 min after injection

    Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied.

  2. Quantitative Amyloid Image Assessment

    Time frame: 50-60 minutes after injection

    The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

A Study Evaluating the Imaging Characteristics of Florbetapir 18F (18F-AV-45) in Patients With Frontotemporal Dementia Compared to Patients With Alzheimer's Disease and Normal Controls.

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jul 1, 2013
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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