Alzheimer's Disease
Conditions
Keywords
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
Brief summary
This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).
Interventions
DRUGflorbetapir F 18
IV injection, 370MBq (10mCi)
Sponsors
Avid Radiopharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
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
| Measure | Time frame | Description |
|---|---|---|
| Mean Cortical to Cerebellum SUVR | 50-70 min after injection | Standardized 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
| Arm | Count |
|---|---|
| AD Subjects Male or female subjects \> 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24 | 11 |
| AD Subjects: Slow vs. Fast Bolus Group Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration). | 4 |
| Control Subjects Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher | 10 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative decision/technical issues | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | AD Subjects | AD Subjects: Slow vs. Fast Bolus Group | Control Subjects | Total |
|---|---|---|---|---|
| Age Continuous | 69.7 years STANDARD_DEVIATION 10.66 | 79.0 years STANDARD_DEVIATION 3.56 | 44.4 years STANDARD_DEVIATION 5.64 | 61.1 years STANDARD_DEVIATION 16.3 |
| Region of Enrollment United States | 11 participants | 4 participants | 10 participants | 25 participants |
| Sex: Female, Male Female | 9 Participants | 3 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 6 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 11 | 0 / 4 | 1 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 4 | 0 / 10 |
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: 50-70 min after injection
Population: Due to poor subject positioning that resulted in an incomplete brain image on the retest image day, accurate quantitative analysis for one healthy control was not possible, and the subject was excluded from the SUVR-based analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AD Subjects | Mean Cortical to Cerebellum SUVR | Test (50-70 min) | 1.416 SUVR | Standard Deviation 0.245 |
| AD Subjects | Mean Cortical to Cerebellum SUVR | Retest (50-70 min) | 1.407 SUVR | Standard Deviation 0.269 |
| Control Subjects | Mean Cortical to Cerebellum SUVR | Test (50-70 min) | 1.005 SUVR | Standard Deviation 0.055 |
| Control Subjects | Mean Cortical to Cerebellum SUVR | Retest (50-70 min) | 1.007 SUVR | Standard Deviation 0.061 |
Comparison: Intra-class Correlation Coefficient (ICC) of AD subjects 50-70 min test vs. retest valuesICC
Comparison: Intra-class Correlation Coefficient of Control subjects 50-70 min test vs. retest valuesICC
Comparison: Intra-subject variability (% difference) of AD subjects 50-70 min test vs. retest values
Comparison: Intra-subject variability (% difference) of control subjects 50-70 min test vs. retest values