Florbetapir Calibration to the Centiloid Scale
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | September 2015 |
A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB
This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission
Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.
Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.
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
We found this trial at
2
sites
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