Alzheimer's Disease
Conditions
Keywords
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
Brief summary
This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.
Interventions
DRUGflorbetapir F 18
IV injection, 111 or 370MBq (3 or 10mCi), single dose
Sponsors
Avid Radiopharmaceuticals
Study design
Allocation
NA
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
Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A01(NCT01565291) or A03(NCT01565330). 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 (A01\[NCT01565291\] healthy volunteer group): * 50 years of age, inclusive * MMSE of 29 or greater Inclusion Criteria (A03\[NCT01565330\] 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 |
|---|---|---|
| Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation | Scans acquired 30-40 min and 50-60 min after injection | Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation | Scans acquired 30-40 min and 50-60 min post-injection | Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic. |
Participant flow
Recruitment details
NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies
Participants by arm
| Arm | Count |
|---|---|
| All Subject Scans 22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03 | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | All Subject Scans |
|---|---|
| Age Continuous | 65.49 years STANDARD_DEVIATION 15.302 |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation
Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.
Time frame: Scans acquired 30-40 min and 50-60 min after injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Scans | Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation | 100 percentage of agreement |
Comparison: Cohen's (simple) kappa statistic95% CI: [1, 1]
Secondary
Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation
Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.
Time frame: Scans acquired 30-40 min and 50-60 min post-injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Scans | Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation | 0.946 weighted kappa |