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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01890343
First received: June 27, 2013
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
Frontotemporal Dementia
Drug: florbetapir 18F
Drug: 18F-FDG
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official 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.

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Qualitative Amyloid Image Assessment [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
    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.

  • Quantitative Amyloid Image Assessment [ Time Frame: 50-60 minutes after injection ] [ Designated as safety issue: No ]
    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).


Enrollment: 34
Study Start Date: September 2009
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Frontotemporal Disorder
Subjects with frontotemporal disorder (FTD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F and a one-time IV bolus injection of 185 MBq of 18F-FDG.
Drug: florbetapir 18F
Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Other Names:
  • Florbetapir F 18
  • 18F-AV-45
  • Amyvid
Drug: 18F-FDG
FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
Other Names:
  • FDG
  • fluorodeoxyglucose (18F)
  • fludeoxyglucose (18F)
Experimental: Cognitively Normal
Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Drug: florbetapir 18F
Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Other Names:
  • Florbetapir F 18
  • 18F-AV-45
  • Amyvid
Experimental: Alzheimer's Disease
Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Drug: florbetapir 18F
Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Other Names:
  • Florbetapir F 18
  • 18F-AV-45
  • Amyvid

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890343

Locations
United Kingdom
Research Site
Manchester, United Kingdom, M20 3LJ
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01890343     History of Changes
Other Study ID Numbers: 18F-AV-45-010
Study First Received: June 27, 2013
Results First Received: September 10, 2014
Last Updated: September 16, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Frontotemporal Dementia
Pick Disease of the Brain
Alzheimer Disease
Dementia
Aphasia, Primary Progressive
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014