A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers
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ClinicalTrials.gov Identifier: NCT01565291 |
Recruitment Status :
Completed
First Posted : March 28, 2012
Results First Posted : May 3, 2012
Last Update Posted : May 18, 2012
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease | Drug: florbetapir F 18 | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | January 2008 |

Arm | Intervention/treatment |
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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)
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Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
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Experimental: Healthy Elderly Subjects
Cognitively normal with MMSE of 29 or higher; age 50 years or older
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Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single dose
Other Names:
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- Mean Cortical to Cerebellum SUVR [ Time Frame: 50-60 min after injection ]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.
- Precuneus to Cerebellum SUVR [ Time Frame: 50-60 min after injection ]Ratio of uptake in the precuneus to uptake in the cerebellum.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565291
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 |
Study Director: | Chief Medical Officer | Avid Radiopharmaceuticals |
Responsible Party: | Avid Radiopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01565291 |
Other Study ID Numbers: |
18F-AV-45-A01 |
First Posted: | March 28, 2012 Key Record Dates |
Results First Posted: | May 3, 2012 |
Last Update Posted: | May 18, 2012 |
Last Verified: | May 2012 |
Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |