Florbetapir Calibration to the Centiloid Scale

NCT ID: NCT02120664

Last Updated: 2017-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-09-30

Brief Summary

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

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Amyloid Negative Subjects

Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie \[mCi\]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.

Group Type: EXPERIMENTAL

Florbetapir (18F)

Intervention Type: DRUG

11C-PiB

Intervention Type: DRUG

Amyloid Positive Subjects

Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.

Group Type: EXPERIMENTAL

Florbetapir (18F)

Intervention Type: DRUG

11C-PiB

Intervention Type: DRUG

Interventions

Florbetapir (18F)

Intervention Type: DRUG

11C-PiB

Intervention Type: DRUG

Other Intervention Names

Florbetapir F 18; Amyvid; 18F-AV-45; Pittsburgh Compound B

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_CHAIR

Avid Radiopharmaceuticals, Inc.

Locations

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Heidelberg, Victoria, Australia

Countries

United States; Australia

References

Klunk WE, Koeppe RA, Price JC, Benzinger TL, Devous MD Sr, Jagust WJ, Johnson KA, Mathis CA, Minhas D, Pontecorvo MJ, Rowe CC, Skovronsky DM, Mintun MA. The Centiloid Project: standardizing quantitative amyloid plaque estimation by PET. Alzheimers Dement. 2015 Jan;11(1):1-15.e1-4. doi: 10.1016/j.jalz.2014.07.003. Epub 2014 Oct 28.

Reference Type: BACKGROUND

PMID: 25443857 (View on PubMed)

Other Identifiers

18F-AV-45-A22

Identifier Type: -

Identifier Source: org_study_id