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Bridging Study of C11 PiB and F18 Flutemetamol Brain PET

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Val Lowe, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01607476
First received: May 23, 2012
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Alzheimer's Disease
 Drug: C11 PiB
Drug: F18 Flutemetamol
Drug: FDG

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bridging Study of C11 PiB and F18 Flutemetamol Brain PET

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Distribution of C11 PiB and F18 Flutemetamol to areas of amyloid deposition in the brain. [ Time Frame: Subjects will be followed for the length of time is takes to complete the scans. ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alzheimer's Disease
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)
 Drug: C11 PiB
One time intravenous administration of 8-22 mCi C11 PiB
Drug: F18 Flutemetamol
One time intravenous administration of 3-7 mCi F18 Flutemetamol.
Drug: FDG
One time intravenous administration of 10 mCi (+/- 20%) FDG.
Active Comparator: Cognitive Normal Elderly
Cognitive Normal subjects who are greater than 60 years of age.
 Drug: C11 PiB
One time intravenous administration of 8-22 mCi C11 PiB
Drug: F18 Flutemetamol
One time intravenous administration of 3-7 mCi F18 Flutemetamol.
Drug: FDG
One time intravenous administration of 10 mCi (+/- 20%) FDG.
Active Comparator: Cognitive Normal Young
Cognitively normal subjects who are between 30-60 years old.
 Drug: C11 PiB
One time intravenous administration of 8-22 mCi C11 PiB
Drug: F18 Flutemetamol
One time intravenous administration of 3-7 mCi F18 Flutemetamol.
Drug: FDG
One time intravenous administration of 10 mCi (+/- 20%) FDG.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607476

Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Val Lowe, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Val Lowe, Consultant - Diagnostic Radiology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01607476     History of Changes
Other Study ID Numbers: 12-000118
Study First Received: May 23, 2012
Last Updated: January 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013