Biodistribution of 11C-PIB PET in Alzheimer's Disease, Frontotemporal Dementia, and Cognitively Normal Elderly

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00811122
First received: December 16, 2008
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

Alzheimer's disease (AD) is characterized by neuritic plaques, neurofibrillary tangles, and neuronal cell loss. Amyloid plaques are believed to play an integral role in AD. Elevated levels of Aβ in the brain are correlated with cognitive decline.

There are no approved ways to measure amyloid load in humans. Several compounds are under investigation. All of these compounds use radioactive chemical tags for positron emission tomography (PET) imaging. The most promising compound is 11C-PIB, or Pittsburgh Compound-B. This compound can be injected and a PET scan performed. This allows doctors to see the amyloid plaques in the brain, and to use this information to look at other types of dementia to see if there are differences and/or similarities in the plaques.

We will recruit a total of 30 subjects, 10 from each of the following three diagnostic categories: frontotemporal dementia (FTD), Alzheimer's disease, and normal volunteers. All subjects will be given an [18F]fluorodeoxyglucose or FDG-PET scan (if they haven't had one in the past) and a PIB-PET scan.

The overall objective of this project is to study the biodistribution of 11C-PIB using PET imaging in normal elderly volunteers and relevant patient groups.


Condition Intervention
Alzheimer's Disease
Radiation: 11C-PIB PET Scan
Radiation: FDG-PET Scan

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Biodistribution of 11C-PIB PET in Alzheimer's Disease, Frontotemporal Dementia, and Cognitively Normal Elderly

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • The agent 11C-PIB has similar biodistribution outside the brain in AD, FTD, and cognitively normal elderly individuals. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients with AD scanned with 11C-PIB will have higher standardized uptake values (SUVs) than cognitively normal elderly in brain regions where beta amyloid are expected to be over-expressed. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: 11C-PIB PET Scan
    Each of the 30 participants will receive an 11C-PIB PET scan of the brain. A subset (6 participants) will receive a whole body 11C-PIB PET scan to determine relative biodistribution of 11C-PIB.
    Other Name: N-methyl-[11C]2-(4 - methylaminophenyl)-6-hydroxybenzothiazole, 11 Carbon Pittsburgh compound B
    Radiation: FDG-PET Scan
    Each of the 30 participants will receive an FDG-PET scan of the brain. To minimize radiation exposure, FDG-PET scans will not be repeated if available from a previous clinical study.
    Other Name: 2-deoxy-2-[18F]fluoro-D-glucose (FDG)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All participants will be between 30-90 years old, inclusive, clinically characterized as having AD, having FTD, or being cognitively normal controls (NC).
  2. All subjects must be willing and able to undergo testing procedures.
  3. Cholinesterase inhibitors and memantine - symptomatic drugs approved for AD - will be allowed since these drugs are not expected to significantly affect amyloid load.

General inclusion criteria are shown below:

  1. Normal subjects: Healthy individuals aged to match AD and FTD groups, who are non-depressed, non-demented, and without a complaint of memory loss. A brief neuropsychological test, the 3MS-R or Modified Mini-Mental State Examination, Revised (Tschanz et al., 2002), will be given to confirm that the subject is not cognitively impaired.
  2. FTD subjects: Patients seen in the University of Utah (UU) Cognitive Disorders Clinic (CDC) who have been clinically characterized and meet Neary criteria for frontotemporal dementia (Neary et al., 1998).
  3. AD subjects: Patients seen in the UU CDC who have been clinically characterized to meet NINCDS-ADRDA criteria for probable AD (McKhann et al., 1984). These criteria were established in 1984 for diagnosis of AD by the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA).

Exclusion Criteria:

  1. Subjects with medical conditions that have a high risk of associated cognitive symptoms such as transient ischemic attack (TIA), stroke, seizures, or head injury with loss of consciousness within five years
  2. Subjects with Axis I psychiatric diagnoses other than treated depression
  3. Subjects who are not medically stable will be excluded from the study. Examples of medically unstable patients include uncontrolled hypertension, heart/liver/renal failure, and other conditions requiring acute medical attention
  4. Subjects cannot have a serum glucose level greater than 180 mg/dl for FDG-PET imaging
  5. Subjects who are too claustrophobic to undergo FDG-PET or 11C PIB-PET imaging
  6. Subjects who require conscious sedation or anesthesia to undergo FDG-PET or 11C PIB-PET imaging
  7. Subjects who are unable to follow instructions to urinate after completing scanning procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811122

Locations
United States, Utah
University of Utah Center for Alzheimer's Care, Imaging and Research
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Norman L Foster, MD University of Utah Center for Alzheimer's Care, Imaging and Research
  More Information

Additional Information:
No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00811122     History of Changes
Other Study ID Numbers: 17991
Study First Received: December 16, 2008
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Alzheimer's disease
AD
Frontotemporal dementia
FTD

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014