Bridging Study of C11 Pittsburgh Compound B (PiB) and F18 Flutemetamol Brain Positron Emission Tomography (PET)

NCT ID: NCT01607476

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-03-31

Brief 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 Alzheimer's disease (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.

Detailed Description

Some of the current thinking in regards to the pathophysiology of AD involves the production of amyloid Beta protein (AB) by secretase processing of amyloid precursor protein (APP). While AB is thought to be toxic to neurons its role leading to AD pathogenesis, this is not without debate. In any case, it appears that AB forms amyloid plaques that are largely ubiquitous in AD. Neuronal cell death as a result of the disease is another clear pathophysiologic finding. Because of the importance of these findings in the development of AD, targeted therapies are being investigated to selectively inhibit AB production and/or manipulate amyloid load.

Positron emission tomography (PET) is a molecular imaging modality used to noninvasively measure functional processes of the body. A trace amount of a radiopharmaceutical is injected into a patient and the radiopharmaceutical will be taken up or localized in the body as a function of certain biological processes. The detectors of a PET scanner then measure the radiopharmaceutical distribution externally and the reconstructed PET images should represent the true distribution of the radiopharmaceutical within the body.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Alzheimer's Disease

Subjects who have the clinical diagnosis of probable AD ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).

Interventions include C11 PiB PET/CT and F-18 Flutametamol PET/CT with C11 PiB PET/CT performed first.

Group Type: EXPERIMENTAL

C11 PiB

Intervention Type: DRUG

One time intravenous administration of 8-22 millicurie (mCi) C11 PiB

F18 Flutametamol

Intervention Type: DRUG

One time intravenous administration of 3-7 mCi F18 Flutametamol.

Cognitive Normal Elderly

Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT and F-18 Flutametamol PET/CT with C11 PiB PET/CT performed first.

Group Type: ACTIVE_COMPARATOR

C11 PiB

Intervention Type: DRUG

One time intravenous administration of 8-22 millicurie (mCi) C11 PiB

F18 Flutametamol

Intervention Type: DRUG

One time intravenous administration of 3-7 mCi F18 Flutametamol.

Cognitive Normal Young

Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT and F-18 Flutametamol PET/CT with C11 PiB PET/CT performed first.

Group Type: ACTIVE_COMPARATOR

C11 PiB

Intervention Type: DRUG

One time intravenous administration of 8-22 millicurie (mCi) C11 PiB

F18 Flutametamol

Intervention Type: DRUG

One time intravenous administration of 3-7 mCi F18 Flutametamol.

Interventions

C11 PiB

One time intravenous administration of 8-22 millicurie (mCi) C11 PiB

Intervention Type: DRUG

F18 Flutametamol

One time intravenous administration of 3-7 mCi F18 Flutametamol.

Intervention Type: DRUG

Other Intervention Names

C11 PiB PET/CT; C11 Pittsburgh Compound B; F18 Flutametamol PET/CT; Vizamyl

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Val Lowe

Consultant - Diagnostic Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Val Lowe, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

12-000118

Identifier Type: -

Identifier Source: org_study_id