Phase 2
N=152
Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)
Alzheimer's Disease · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT00857506 ↗Enrolled (actual)
152
Serious AEs
1.2%
Results posted
Mar 2013
Primary outcome: Primary: Change in ADAS-Cog for MCI Subjects — 5.664; -0.710 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- florbetapir F 18 (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Avid Radiopharmaceuticals
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in ADAS-Cog for MCI Subjects |
5.664; -0.710 | — |
| SECONDARY Cognitive Decline in MCI Subjects |
8; 3; 5; 4; 6; 3 | — |
| SECONDARY Change in ADAS-Cog in CN and AD Subjects |
3.237; -0.094; 8.879; 3.811 | — |
| SECONDARY Cognitive Decline in CN and AD Subjects |
4; 3; 14; 3; 4; 5 | — |
| SECONDARY Covariate Adjusted Psychometric Score Change |
-6.521; 0.214; -10.940; 0.133; -5.995; -0.011 | — |
| SECONDARY Correlation of Change in ADAS-Cog and SUVR |
0.364; 0.502; 0.308 | — |
Summary
The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease.
Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative.
The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET.
Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.
Eligibility Criteria
Inclusion Criteria
- All subjects who enrolled in study AV-45-A05(NCT00702143), received 18F-AV-45, and completed a PET scan will be eligible to enroll in this trial.
Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT00857506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.