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

Purpose

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.

Condition	Intervention	Phase
Alzheimer Disease	Drug: florbetapir F 18	Phase 0


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Florbetapir F-18

Genetic and Rare Diseases Information Center resources: Alzheimer Disease Familial

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	32
Study Start Date:	June 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)	Drug: florbetapir F 18 IV injection, 370MBq (10mCi), single dose Other Names: 18F-AV-45 Amyvid florbetapir
Experimental: Healthy Elderly Subjects Cognitively normal with MMSE of 29 or higher; age 50 years or older	Drug: florbetapir F 18 IV injection, 370MBq (10mCi), single dose Other Names: 18F-AV-45 Amyvid florbetapir

Eligibility


Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

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: NCT01565291

Locations


United States, Maryland
Research Site
Baltimore, Maryland, United States, 21287
Research Site
North East, Maryland, United States, 21901
United States, New Jersey
Research Site
Long Branch, New Jersey, United States, 07740

Sponsors and Collaborators

Avid Radiopharmaceuticals

Investigators


Study Director:	Chief Medical Officer	Avid Radiopharmaceuticals

More Information

Publications:

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. doi: 10.2967/jnumed.109.069088. Erratum in: J Nucl Med. 2010 Aug;51(8):1327.


Responsible Party:	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT01565291 History of Changes
Other Study ID Numbers:	18F-AV-45-A01
Study First Received:	March 25, 2012
Results First Received:	April 6, 2012
Last Updated:	May 11, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:


Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging

Additional relevant MeSH terms:


Alzheimer Disease Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia	Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies

ClinicalTrials.gov processed this record on February 27, 2015