Florbetapir Calibration to the Centiloid Scale

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Avid Radiopharmaceuticals
• Treatments: Corticosterone

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