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CompletedNCT01565291Updated May 18, 2012Results posted

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

An Early Phase 1 interventional study of florbetapir F 18 in Alzheimer Disease, sponsored by Avid Radiopharmaceuticals. Completed at 3 sites in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-18.

Sponsored by Avid Radiopharmaceuticals · Early Phase 1, Interventional, and Diagnostic

Phase
Early Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Alzheimer Disease

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Keywords

  • Amyloid imaging
  • Positron Emission Tomography
  • 18F-AV-45
  • florbetapir F 18
  • Diagnostic imaging
03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 32 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Avid Radiopharmaceuticals is the lead sponsor of 54 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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

  • Experimental
    Healthy Elderly Subjects

    Cognitively normal with MMSE of 29 or higher; age 50 years or older

    Drug: florbetapir F 18

Interventions

  • Drugflorbetapir F 18

    IV injection, 370MBq (10mCi), single dose

    Also known as: 18F-AV-45, Amyvid, florbetapir

06

What researchers measure

Primary outcomes

  1. Mean Cortical to Cerebellum SUVR

    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.

    Time frame: 50-60 min after injection

Secondary outcomes

  1. Precuneus to Cerebellum SUVR

    Ratio of uptake in the precuneus to uptake in the cerebellum.

    Time frame: 50-60 min after injection

07

Results

Posted May 3, 2012

Participant flow

Participant flow — Overall Study
MilestoneSubjects With ADHealthy Elderly Subjects
Started1616
Completed1516
Not completed10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryMean Cortical to Cerebellum SUVR

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.

Time frame:
50-60 min after injection
Reported as:
Mean · SUVR
Mean Cortical to Cerebellum SUVR
SUVRSubjects With ADHealthy Elderly Subjects
Mean Cortical to Cerebellum SUVR1.665 ± 0.1751.246 ± 0.177
SecondaryPrecuneus to Cerebellum SUVR

Ratio of uptake in the precuneus to uptake in the cerebellum.

Time frame:
50-60 min after injection
Reported as:
Mean · SUVR
Precuneus to Cerebellum SUVR
SUVRSubjects With ADHealthy Elderly Subjects
Precuneus to Cerebellum SUVR1.847 ± 0.2371.300 ± 0.271

Adverse events

Collected over AEs occuring within 3 days of injection. SAEs occuring within 30 days of injection. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Subjects With AD—0/16 (0%)0/16 (0%)
Healthy Elderly Subjects—0/16 (0%)2/16 (12.5%)
Most frequent other events
Most frequent other events
EventSubjects With ADHealthy Elderly Subjects
HEADACHENervous system disorders0/161/16
CLAUSTROPHOBIAPsychiatric disorders0/161/16

Baseline characteristics

Age Continuous
Age Continuous(years)Subjects With ADHealthy Elderly SubjectsTotal
Mean75.8 ± 9.272.5 ± 11.5674.3 ± 10.44
Sex: Female, Male
Sex: Female, Male(Participants)Subjects With ADHealthy Elderly SubjectsTotal
Female8614
Male81018
Region of Enrollment
Region of Enrollment(participants)Subjects With ADHealthy Elderly SubjectsTotal
United States161632
08

Study locations

3 sites
  • Research Site
    Baltimore, Maryland 21287, United States
  • Research Site
    North East, Maryland 21901, United States
  • Research Site
    Long Branch, New Jersey 07740, United States
09

References and documents

Publications

  • Wong DF, Rosenberg PB, Zhou Y, Kumar A, Raymont V, Ravert HT, Dannals RF, Nandi A, Brasic 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. PubMed 20501908 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01565291
Lead sponsor
Avid Radiopharmaceuticals
Responsible party
Sponsor
First posted
Mar 28, 2012
Start date
Jun 2007
Primary completion
Jan 2008
Completion
Jan 2008
Results posted
May 3, 2012
Last update
May 18, 2012

Study contacts

Chief Medical Officer
study director · Avid Radiopharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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