A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01565291
First received: March 25, 2012
Last updated: May 11, 2012
Last verified: May 2012

March 25, 2012
May 11, 2012
June 2007
January 2008   (final data collection date for primary outcome measure)
Mean Cortical to Cerebellum SUVR [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min.
Mean Cortical Standardized Uptake Value (SUV) [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]

Average of SUVs from the following cortical regions determined by brain PET scan: frontal cortex, temporal cortex, parietal cortex, occipital cortex, anterior cingulate, posterior cingulate, precuneus.

SUV=An automated process to extract estimates of tracer retention on a PET scan from prespecified standard volumes of interest.

Complete list of historical versions of study NCT01565291 on ClinicalTrials.gov Archive Site
Precuneus to Cerebellum SUVR [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]
Ratio of uptake in the precuneus to uptake in the cerebellum.
  • Mean Cortical SUVR to the cerebellum [ Time Frame: 50-60 min after injection ] [ Designated as safety issue: No ]

    SUVR=SUV ratio

    Ratio of mean cortical SUV to cerebellum SUV

  • Plasma Radioactivity [ Time Frame: 0, 3, 4, 5, 7.5, 10, 15, 20, 30, 45, 60, 90, 130, 190 min after injection ] [ Designated as safety issue: No ]
    Total activity determined by gamma counter
  • Whole body radiation dosimetry [ Time Frame: 0-200 min after injection ] [ Designated as safety issue: No ]
    Radiation dose values (millisievert/megabecquerel [mSv/MBq]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine, small intestine, stomach, upper large intestine, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, red marrow, bone surfaces, salivary glands, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.
Not Provided
Not Provided
 
A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers
A Preliminary Evaluation of the Amyloid Binding Properties, Pharmacokinetics and Safety of 18F-AV-45 in Healthy Elderly Volunteers and Patients With Alzheimer's Disease

A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.

Not Provided
Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Alzheimer Disease
Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
  • 18F-AV-45
  • Amyvid
  • florbetapir
  • Experimental: Subjects With AD
    Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24)
    Intervention: Drug: florbetapir F 18
  • Experimental: Healthy Elderly Subjects
    Cognitively normal with MMSE of 29 or higher; age 50 years or older
    Intervention: Drug: florbetapir F 18
Wong DF, Rosenberg PB, Zhou Y, Kumar A, Raymont V, Ravert HT, Dannals RF, Nandi A, Brasić JR, Ye W, Hilton J, Lyketsos C, Kung HF, Joshi AD, Skovronsky DM, Pontecorvo MJ. In vivo imaging of amyloid deposition in Alzheimer disease using the radioligand 18F-AV-45 (florbetapir [corrected] F 18). J Nucl Med. 2010 Jun;51(6):913-20. Erratum in: J Nucl Med. 2010 Aug;51(8):1327.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria (AD group):

  • Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Mild/moderate dementia as evidenced by a mini mental state exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
  • History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

  • No evidence of significant cognitive impairment by history and psychometric testing
  • MMSE of 29 or higher

Exclusion Criteria (both groups):

  • Neurodegenerative disorders other than AD
  • Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
  • Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
  • Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
  • Clinically significant psychiatric disease
  • History of epilepsy or convulsions
  • Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
  • Current clinically significant cardiovascular disease
  • Received investigational medication within the last 30 days
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01565291
18F-AV-45-A01
No
Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
Not Provided
Study Director: Chief Medical Officer Avid Radiopharmaceuticals
Avid Radiopharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP