FindTrial
Sign In

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

An Open Label, Parallel Group, Dose Comparison of Safety and Imaging Characteristics of 111 and 370 MBq (3 and 10 mCi) of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Patients With Alzheimer's Disease (AD)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01565330
Enrollment
20
Registered
2012-03-28
Start date
2008-03-31
Completion date
2008-08-31
Last updated
2012-06-18

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

Conditions

Alzheimer Disease

Keywords

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

Brief summary

This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.

Interventions

DRUGflorbetapir F 18

single dose IV injection

Sponsors

Avid Radiopharmaceuticals
Lead SponsorINDUSTRY

Study design

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

Eligibility

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

Inclusion criteria

(AD group): * Greater than 50 years of age * 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 Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening * History of cognitive decline gradual in onset and progressive over a period of at least 6 months Inclusion Criteria (healthy volunteer group): * 35 to 55 years of age, inclusive * MMSE of 29 or greater

Exclusion criteria

(both groups): * Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy * Diagnosis of other dementing / neurodegenerative disease * Diagnosis of mixed dementia * 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

Design outcomes

Primary

MeasureTime frameDescription
Florbetapir-PET Scan Quality0-90 min after injectionVisual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).

Secondary

MeasureTime frameDescription
Mean Cortical to Cerebellum SUVR0-90 min after injectionStandardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

Countries

United States

Participant flow

Participants by arm

ArmCount
111 MBq (3 mCi) AD Group
Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
5
111 MBq (3 mCi) Control Group
Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
4
370 MBq (10 mCi) AD Group
Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
4
370 MBq (10 mCi) Control Group
Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
7
Total20

Baseline characteristics

Characteristic111 MBq (3 mCi) AD Group111 MBq (3 mCi) Control Group370 MBq (10 mCi) AD Group370 MBq (10 mCi) Control GroupTotal
Age Continuous74.8 years
STANDARD_DEVIATION 11.01
48.0 years
STANDARD_DEVIATION 6.73
76.8 years
STANDARD_DEVIATION 10.24
45.0 years
STANDARD_DEVIATION 6.88
59.4 years
STANDARD_DEVIATION 17.14
Region of Enrollment
United States
5 participants4 participants4 participants7 participants20 participants
Sex: Female, Male
Female
2 Participants1 Participants2 Participants1 Participants6 Participants
Sex: Female, Male
Male
3 Participants3 Participants2 Participants6 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 50 / 40 / 42 / 7
serious
Total, serious adverse events
0 / 50 / 40 / 40 / 7

Outcome results

Primary

Florbetapir-PET Scan Quality

Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).

Time frame: 0-90 min after injection

Population: One subject in the 370 MBq (10 mCi) AD Group did not complete all imaging time periods

ArmMeasureGroupValue (NUMBER)
111 MBq (3 mCi) AD GroupFlorbetapir-PET Scan Quality43 florbetapir scans
111 MBq (3 mCi) AD GroupFlorbetapir-PET Scan Quality21 florbetapir scans
111 MBq (3 mCi) AD GroupFlorbetapir-PET Scan Quality5 - Excellent0 florbetapir scans
111 MBq (3 mCi) AD GroupFlorbetapir-PET Scan Quality31 florbetapir scans
111 MBq (3 mCi) AD GroupFlorbetapir-PET Scan Quality1 - Poor0 florbetapir scans
111 MBq (3 mCi) Control GroupFlorbetapir-PET Scan Quality33 florbetapir scans
111 MBq (3 mCi) Control GroupFlorbetapir-PET Scan Quality40 florbetapir scans
111 MBq (3 mCi) Control GroupFlorbetapir-PET Scan Quality5 - Excellent0 florbetapir scans
111 MBq (3 mCi) Control GroupFlorbetapir-PET Scan Quality21 florbetapir scans
111 MBq (3 mCi) Control GroupFlorbetapir-PET Scan Quality1 - Poor0 florbetapir scans
370 MBq (10 mCi) AD GroupFlorbetapir-PET Scan Quality32 florbetapir scans
370 MBq (10 mCi) AD GroupFlorbetapir-PET Scan Quality1 - Poor0 florbetapir scans
370 MBq (10 mCi) AD GroupFlorbetapir-PET Scan Quality20 florbetapir scans
370 MBq (10 mCi) AD GroupFlorbetapir-PET Scan Quality42 florbetapir scans
370 MBq (10 mCi) AD GroupFlorbetapir-PET Scan Quality5 - Excellent0 florbetapir scans
370 MBq (10 mCi) Control GroupFlorbetapir-PET Scan Quality43 florbetapir scans
370 MBq (10 mCi) Control GroupFlorbetapir-PET Scan Quality20 florbetapir scans
370 MBq (10 mCi) Control GroupFlorbetapir-PET Scan Quality1 - Poor0 florbetapir scans
370 MBq (10 mCi) Control GroupFlorbetapir-PET Scan Quality34 florbetapir scans
370 MBq (10 mCi) Control GroupFlorbetapir-PET Scan Quality5 - Excellent0 florbetapir scans
Secondary

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: 0-90 min after injection

ArmMeasureValue (MEAN)Dispersion
111 MBq (3 mCi) AD GroupMean Cortical to Cerebellum SUVR1.781 SUVRStandard Deviation 0.217
111 MBq (3 mCi) Control GroupMean Cortical to Cerebellum SUVR0.968 SUVRStandard Deviation 0.05
370 MBq (10 mCi) AD GroupMean Cortical to Cerebellum SUVR1.658 SUVRStandard Deviation 0.288
370 MBq (10 mCi) Control GroupMean Cortical to Cerebellum SUVR0.988 SUVRStandard Deviation 0.093

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