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A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00702143
Enrollment
184
Registered
2008-06-20
Start date
2008-06-30
Completion date
2008-12-31
Last updated
2012-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Mild Cognitive Impairment

Brief summary

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Interventions

DRUGflorbetapir F 18

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

Sponsors

Avid Radiopharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

AD: * Male or female \>=50 years of age * Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24 Inclusion Criteria MCI: * Male or female \>=50 years of age * Have a Clinical Dementia Rating (CDR) of 0.5 * MMSE \>24 Normal subjects: * Male or female \>=50 years of age * MMSE \>=29 * Normal on psychometric test battery at screening * Provide informed consent

Exclusion criteria

* Have a history or current diagnosis of other neurologic disease * Have had or currently have a diagnosis of other neurodegenerative disease * Have participated in experimental therapy targeted to amyloid plaque

Design outcomes

Primary

MeasureTime frameDescription
Qualitative Amyloid Image Assessment50-60 min after injectionThree 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 was the primary efficacy endpoint for the qualitative evaluation.
Mean Cortical to Cerebellum SUVR50-60 min after injectionStandardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

Secondary

MeasureTime frameDescription
Proportion of Positive Florbetapir-PET Scans50-60 min after injectionThree readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.

Countries

United States

Participant flow

Participants by arm

ArmCount
AD Subjects
Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
45
MCI Subjects
MCI (mild cognitive impairment)
60
Healthy Controls
cognitively normal (healthy) controls
79
Total184

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyLost to Follow-up001

Baseline characteristics

CharacteristicAD SubjectsMCI SubjectsHealthy ControlsTotal
Age Continuous75.4 years
STANDARD_DEVIATION 9.21
71.7 years
STANDARD_DEVIATION 10.23
69.4 years
STANDARD_DEVIATION 11.04
71.6 years
STANDARD_DEVIATION 10.57
Region of Enrollment
United States
45 participants60 participants79 participants184 participants
Sex: Female, Male
Female
19 Participants33 Participants45 Participants97 Participants
Sex: Female, Male
Male
26 Participants27 Participants34 Participants87 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
2 / 184
serious
Total, serious adverse events
1 / 184

Outcome results

Primary

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 whole cerebellum.

Time frame: 50-60 min after injection

Population: One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.

ArmMeasureValue (MEAN)Dispersion
AD SubjectsMean Cortical to Cerebellum SUVR1.404 SUVRStandard Deviation 0.267
MCI SubjectsMean Cortical to Cerebellum SUVR1.199 SUVRStandard Deviation 0.2761
Healthy ControlsMean Cortical to Cerebellum SUVR1.051 SUVRStandard Deviation 0.1585
Comparison: Analysis of variance contrast P value testing for difference in the mean cortical SUVRp-value: 0.0003ANOVA
Comparison: Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.p-value: <0.0001ANOVA
Comparison: Analysis of variance contrast P value testing for difference in the mean cortical SUVRp-value: <0.0001ANOVA
Comparison: Analysis of variance contrast P value testing for difference in the mean cortical SUVRp-value: <0.0001ANOVA
Primary

Qualitative Amyloid Image Assessment

Three 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 was the primary efficacy endpoint for the qualitative evaluation.

Time frame: 50-60 min after injection

Population: One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.

ArmMeasureGroupValue (NUMBER)
AD SubjectsQualitative Amyloid Image AssessmentPositive for amyloid34 participants
AD SubjectsQualitative Amyloid Image AssessmentNegative for amyloid11 participants
MCI SubjectsQualitative Amyloid Image AssessmentPositive for amyloid23 participants
MCI SubjectsQualitative Amyloid Image AssessmentNegative for amyloid37 participants
Healthy ControlsQualitative Amyloid Image AssessmentPositive for amyloid11 participants
Healthy ControlsQualitative Amyloid Image AssessmentNegative for amyloid67 participants
Comparison: Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groupsp-value: 0.0002Fisher Exact
Comparison: Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groupsp-value: <0.0001Fisher Exact
Comparison: Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groupsp-value: 0.0014Fisher Exact
Secondary

Proportion of Positive Florbetapir-PET Scans

Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.

Time frame: 50-60 min after injection

Population: One healthy subject received florbetapir F 18 but due to technical difficulties with the scanner was not imaged and is therefore not included in the efficacy population.

ArmMeasureValue (NUMBER)
AD SubjectsProportion of Positive Florbetapir-PET Scans75.6 percentage of amyoid positive scans
MCI SubjectsProportion of Positive Florbetapir-PET Scans38.3 percentage of amyoid positive scans
Healthy ControlsProportion of Positive Florbetapir-PET Scans14.1 percentage of amyoid positive scans

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026