A Phase 2 interventional study of florbetapir F 18 and [11C]-PIB in Alzheimer's Disease, sponsored by Avid Radiopharmaceuticals. Completed at 1 site in United States. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-26.
Sponsored by Avid Radiopharmaceuticals · Phase 2, Interventional, and Diagnostic
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
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 28 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Avid Radiopharmaceuticals is the lead sponsor of 54 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
370 MBq (10 mCi), intravenous (IV) injection, single dose
Also known as: 18F-AV-45, Amyvid, florbetapir
555 MBq (15 mCi), IV injection, single dose \[11C\]-PIB
Also known as: C-11 PIB
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
| Milestone | Alzheimer's Disease | Healthy Controls |
|---|---|---|
| Started | 13 | 15 |
| Completed | 12 | 14 |
| Not completed | 1 | 1 |
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.
| SUVR | Alzheimer's Disease | Healthy Controls |
|---|---|---|
| Frontal cortex to cerebellum SUVR | 1.33 ± .20 | 1.00 ± .18 |
| Whole brain to cerebellum SUVR | 1.38 ± .15 | 1.06 ± .17 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alzheimer's Disease | — | 0/13 (0%) | 4/13 (30.8%) |
| Healthy Controls | — | 0/15 (0%) | 1/15 (6.7%) |
| Event | Alzheimer's Disease | Healthy Controls |
|---|---|---|
| Visual DisturbanceEye disorders | 1/13 | 0/15 |
| Injection Site PainGeneral disorders | 1/13 | 0/15 |
| DizzinessNervous system disorders | 1/13 | 0/15 |
| HeadacheNervous system disorders | 1/13 | 0/15 |
| HypertensionVascular disorders | 0/13 | 1/15 |
| Age Continuous(years) | Alzheimer's Disease | Healthy Controls | Total |
|---|---|---|---|
| Mean | 69.8 ± 9.88 | 71.5 ± 9.23 | 70.7 ± 9.39 |
| Sex: Female, Male(Participants) | Alzheimer's Disease | Healthy Controls | Total |
|---|---|---|---|
| Female | 11 | 8 | 19 |
| Male | 2 | 7 | 9 |
| Region of Enrollment(participants) | Alzheimer's Disease | Healthy Controls | Total |
|---|---|---|---|
| United States | 13 | 15 | 28 |
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Avid Radiopharmaceuticals