Florbetapir Calibration to the Centiloid Scale

Avid Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Florbetapir (18F); Drug: 11C-PiB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02120664

18F-AV-45-A22

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Amyloid Negative Subjects

Experimental group

Description:

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.

Treatment:

Drug: 11C-PiB

Drug: Florbetapir (18F)

Amyloid Positive Subjects

Experimental group

Description:

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.

Treatment:

Drug: 11C-PiB

Drug: Florbetapir (18F)