Bridging Study of C11 PiB and F18 Flutemetamol Brain PET

Alzheimer's Disease Clinical Trial

Official title:

Bridging Study of C11 PiB and F18 Flutemetamol Brain PET

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607476
• Other study ID #: 12-000118
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2012
• Last updated: March 9, 2016
• Start date: July 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or to other normal brain structures. Recent data have shown similarity in the distribution of the drugs in subjects with AD or mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has been published. It is important to understand differences in the images and biodistribution from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain structures such as white matter appear to differ slightly and could affect image performance.

The current clinical functional imaging standard for patients with indeterminate cognitive impairment is FDG PET. To allow a comparison of the PET amyloid imaging compounds with FDG PET, FDG PET scans will also be important to acquire in the subjects for comparison.

Description:

The specific aims of this research proposal are outlined below.

1. Compare C11 PiB and F18 Flutemetamol in the same subjects to determine their diagnostic accuracy in AD and normal subjects.

We have conduced 800 C11 PiB PET scans in subjects at Mayo. Only one of these subjects was imaged with both C11 PiB and an F18 amyloid imaging agent (AV-138). Subtle differences are noted in the intensity of accumulation possibly due to the isotope differences as can be seen in the figure below (Figure 1). These data are not sufficient to understand the different characteristics or determine equivalent accuracy of the C11 and F18 drugs. We therefore propose acquiring sufficient data to help characterize the two drugs. We will scan both AD and normal subjects to allow us to understand the diagnostic accuracy of the two drugs.

2. Determine the relative differences in biodistribution of the PET agents and what corrections could be made to allow for adjustments of the data obtained using C11 PiB that will allow accurate comparisons with F18 Flutemetamol data in the same subjects.

If biodistribution differences in the two drugs are found, we will attempt to estimate quantitative correction factors in the C11 images to help to data obtained from the scans be comparable to future serial F18 Flutemetamol data.

3. Acquire FDG PET in the subjects to compare FDG PET imaging to PiB imaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

1. Males or females 30 years of age or older.

2. Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR), cognitive normal elderly (30) age >60 and cognitive normal young subjects (30) ages 30-60.

3. Normal subjects with Clinical Dementia Rating (CDR) 0-0.5 and AD subjects with CDR of 0.5 or greater.

Exclusion Criteria:

1. Subjects unable to lie down without moving for 30 minutes.

2. Women who are pregnant or who cannot stop breast feeding for 24 hours.

3. Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc,.

4. Subjects who are too claustrophobic to perform the tests.

5. Subject who have had previous brain irradiation, stroke or brain tumor(s)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• C11 PiB
One time intravenous administration of 8-22 mCi C11 PiB
• F18 Flutametamol
One time intravenous administration of 3-7 mCi F18 Flutametamol.
• FDG
One time intravenous administration of 10 mCi (+/- 20%) FDG.

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of C11 PiB and F18 Flutemetamol to areas of amyloid deposition in the brain.		Subjects will be in the study for up to 90 days.	No