Phase 1
Completed N=35
Florbetapir Calibration to the Centiloid Scale
Source: ClinicalTrials.gov NCT02120664 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Florbetapir SUVr Conversion to Centiloid Units — 82.44; 50.75; 81.19; 14.93 centiloid
Summary
This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Florbetapir SUVr Conversion to Centiloid Units |
82.44; 50.75; 81.19; 14.93; 5.24 | — |
| SECONDARY Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid |
82.44; 50.75; 81.19; 14.93; 5.24; 87.18 | — |
| SECONDARY Variability of PET Images in Young Healthy Control Subjects. |
1.01; 0.98 | — |
Eligibility Criteria
Inclusion Criteria
- Cognitively Normal Subjects
- Males or females ≥ 21 and ≤ 45 years of age
- Mini-mental state examination (MMSE) ≥ 29
- Clinically Diagnosed AD Subject
- Males or females ≥ 50 years of age
- Meet clinical criteria for dementia due to probable AD
- MMSE ≥ 16 and ≤ 26
- Possible AD Subject
- Males or females ≥ 50 years of age
- Meet clinical criteria for dementia due to possible AD
- MMSE ≥ 16 and ≤ 26
- MCI Subject
- Males or females ≥ 60 years of age with cognitive impairment (not dementia)
- MMSE >24 and <29
- At Risk Elderly Subject
- Cognitively normal males or females that are known ApoE4 carriers and ≥ 75 years of age
- MMSE ≥ 27
Exclusion Criteria
- Have had or currently have a diagnosis of neurodegenerative disorders other than AD
- Have a current serious or unstable illness that could interfere with completion of the study
- Subject has a known brain lesion, pathology or traumatic brain injury
- Have received or participated in a trial with investigational medications in the past 30 days
- Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
Data sourced from ClinicalTrials.gov (NCT02120664). 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. Informational only — not medical advice.