Alzheimer's Disease
Conditions
Keywords
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
Brief summary
This study will evaluate the performance characteristics of a novel \[18F\] amyloid detection ligand (18F\]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of \[11C\]PIB to correctly categorize the same subjects. SPECIFIC HYPOTHESES 1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of \[18F\]-AV-45 compared to cognitively normal elderly individuals. 2. There will be no clinically meaningful difference in the amyloid retention performance characteristics of \[18F\]-AV-45 and \[l1C\]PIB.
Detailed description
15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both \[18F\]-AV-45 and \[11C\]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau.
Interventions
DRUGflorbetapir F 18
370 MBq (10 mCi), intravenous (IV) injection, single dose
DRUG[11C]-PIB
555 MBq (15 mCi), IV injection, single dose \[11C\]-PIB
Sponsors
American College of Radiology Imaging Network
General Electric
Avid Radiopharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating (CDR) = 0, no symptoms of depression * Alzheimer's subjects: MMSE 18-26, CDR \>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI
Exclusion criteria
* other neurological disease * evidence of MRI abnormality * psychiatric disorder * alcohol abuse * clinically significant lab abnormalities * residence in nursing facility * participation in clinical trial with experimental medication in past 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. | 28 d | Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alzheimer's Disease Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) \>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90 | 13 |
| Healthy Controls Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years. | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | Alzheimer's Disease | Healthy Controls | Total |
|---|---|---|---|
| Age Continuous | 69.8 years STANDARD_DEVIATION 9.88 | 71.5 years STANDARD_DEVIATION 9.23 | 70.7 years STANDARD_DEVIATION 9.39 |
| Region of Enrollment United States | 13 participants | 15 participants | 28 participants |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 13 | 1 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
Primary
Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.
Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.
Time frame: 28 d
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alzheimer's Disease | Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. | Frontal cortex to cerebellum SUVR | 1.33 SUVR | Standard Deviation 0.2 |
| Alzheimer's Disease | Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. | Whole brain to cerebellum SUVR | 1.38 SUVR | Standard Deviation 0.15 |
| Healthy Controls | Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. | Frontal cortex to cerebellum SUVR | 1.00 SUVR | Standard Deviation 0.18 |
| Healthy Controls | Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. | Whole brain to cerebellum SUVR | 1.06 SUVR | Standard Deviation 0.17 |